Government-Owned Invention; Availability for Licensing, 87942-87943 [2016-29151]

Download as PDF 87942 Federal Register / Vol. 81, No. 234 / Tuesday, December 6, 2016 / Notices Scientific Review, OD, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, DHHS, 6710B Rockledge Drive, Bethesda, MD 20892–7501, 301–435–6878, wedeenc@ mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: November 29, 2016. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–29141 Filed 12–5–16; 8:45 am] Disorders Research, National Institutes of Health, HHS) Dated: November 28, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–29142 Filed 12–5–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Invention; Availability for Licensing AGENCY: BILLING CODE 4140–01–P National Institutes of Health, HHS. ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute of Dental & Craniofacial Research; Notice of Closed Meeting mstockstill on DSK3G9T082PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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 Dental and Craniofacial Research Special Emphasis Panel. Date: December 12, 2016. Time: 1:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Guo He Zhang, MPH, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute of Dental and Craniofacial Research, National Institutes of Health, 6701 Democracy Boulevard, Suite 672, Bethesda, MD 20892, zhanggu@ 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. 93.121, Oral Diseases and 17:39 Dec 05, 2016 Jkt 241001 The invention listed below is owned by an agency of the U.S. Government and is available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development. FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive Room 4A29, MSC 2479, Bethesda, MD 20892–2479; telephone: 301–402–5579. A signed Confidential Disclosure Agreement may be required to receive any unpublished information. SUPPLEMENTARY INFORMATION: Notice of Licensing of Government-Owned Inventions in accordance with 35 U.S.C. 209 and 37 CFR part 404. Technology description follows. SUMMARY: National Institutes of Health VerDate Sep<11>2014 Notice. ApoA-1 Mimetic Peptides Promoting Lipid Efflux From Cells for Treatment of Vascular Disorders Description of Technology: This invention involves ApoA-1 mimetic peptides with multiple amphipathic alpha-helical domains that promote lipid efflux from cells and are useful in the treatment and prevention of dyslipidemic, inflammatory and vascular disorders. IND-enabling studies for one of the peptides, named Fx–5A, are completed in preparation for an IND filing at the FDA, to be followed by a Phase I clinical trial planned for 2017. Disorders amenable to treatment with the peptides include hyperlipidemia, hyperlipoproteinemia, hypercholesterolemia, HDL deficiency, hypertriglyceridemia, apoA-I deficiency, acute coronary syndrome, angina pectoris, aortic valve stenosis, PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 atherosclerosis, carotid atherosclerosis, congestive heart failure, cerebral stroke, coronary artery disease, inflammation of the cardiovascular system, intermittent claudication, myocardial infarction, peripheral vascular disease, postischemic reperfusion, renal artery stenosis, reperfusion myocardial injury, restenosis, and thrombotic stroke. Potential Commercial Applications: • Treatment and prevention of many hereditary, chronic and acute dyslipidemic and vascular disorders, where other treatments are not effective or too invasive, such as statins, partial ileal bypass surgery, portacaval shunt, liver transplantation, and removal of atherogenic lipoproteins by one of several apheresis procedures. • Also applicable to the treatment of inflammation, asthma, colitis, inflammatory bowel disease (IBD), chronic kidney disease (CKD). Development Stage: Early-stage; In vitro data available; In vivo data available (animal) Inventors: Alan T. Remaley, Stephen J. Demosky, John A. Stonik, Marcelo J.A. Amar, Edward B. Neufeld, Fairwell Thomas, H. Bryan Brewer (all of NHLBI) Publications: 1. Jin X, et al. ABCA1 (ATP-Binding Cassette Transporter A1) Mediates ApoA-I (Apolipoprotein A-I) and ApoA-I Mimetic Peptide Mobilization of Extracellular Cholesterol Microdomains Deposited by Macrophages. Arterioscler Thromb Vasc Biol. 2016 Dec;36(12):2283–2291. [PMID 27758769] 2. Nowacki TM, et al. The 5A apolipoprotein A–I (apoA-I) mimetic peptide ameliorates experimental colitis by regulating monocyte infiltration. Br J Pharmacol. 2016 Sep;173(18):2780–92. [PMID 27425846] 3. Yao X, et al. The A’s Have It: Developing Apolipoprotein A-I Mimetic Peptides Into a Novel Treatment for Asthma. Chest. 2016 Aug;150(2):283–8. [PMID 27327118] 4. Souza AC, et al. Antagonism of scavenger receptor CD36 by 5A peptide prevents chronic kidney disease progression in mice independent of blood pressure regulation. Kidney Int. 2016 Apr;89(4):809–22. [PMID 26994575] 5. Schwendeman A, et al. The effect of phospholipid composition of reconstituted HDL on its cholesterol efflux and anti-inflammatory properties. J Lipid Res. 2015 Sep;56(9):1727–37. [PMID 26117661] 6. Sviridov DO, et al. Hydrophobic amino acids in the hinge region of the 5A apolipoprotein mimetic peptide are essential for promoting cholesterol efflux by the ABCA1 transporter. J Pharmacol Exp Ther. 2013 Jan;344(1):50–8. [PMID 23042953] 7. Dai C, et al. Apolipoprotein A-I attenuates ovalbumin-induced neutrophilic airway inflammation via a granulocyte colony- E:\FR\FM\06DEN1.SGM 06DEN1 87943 Federal Register / Vol. 81, No. 234 / Tuesday, December 6, 2016 / Notices stimulating factor-dependent mechanism. Am J Respir Cell Mol Biol. 2012 Aug;47(2):186–95. [PMID 22427535] 8. Yao X, et al. 5A, an apolipoprotein A-I mimetic peptide, attenuates the induction of house dust mite-induced asthma. J Immunol. 2011 Jan 1;186(1):576–83. [PMID 21115733] 9. Osei-Hwedieh DO, et al. Apolipoprotein mimetic peptides: Mechanisms of action as anti-atherogenic agents. Pharmacol Ther. 2011 Apr;130(1):83–91. [PMID 21172387] 10. D’Souza W, et al. Structure/function relationships of apolipoprotein a-I mimetic peptides: implications for antiatherogenic activities of high-density lipoprotein. Circ Res. 2010 Jul 23;107(2):217–27. [PMID 20508181] 11. Amar MJ, et al. 5A apolipoprotein mimetic peptide promotes cholesterol efflux and reduces atherosclerosis in mice. J Pharmacol Exp Ther. 2010 Aug;334(2):634–41. [PMID 20484557] 12. Tabet F, et al. The 5A apolipoprotein AI mimetic peptide displays antiinflammatory and antioxidant properties in vivo and in vitro. Arterioscler Thromb Vasc Biol. 2010 Feb;30(2):246–52. [PMID 19965776] 13. Sethi AA, et al. Asymmetry in the lipid affinity of bihelical amphipathic peptides. A structural determinant for the specificity of ABCA1–dependent cholesterol efflux by peptides. J Biol Chem. 2008 Nov 21;283(47):32273–82. [PMID 18805791] mstockstill on DSK3G9T082PROD with NOTICES Intellectual Property: NIH Reference No. E–114–2004/0—Issued Patents: • US 7,572,771 issued 2009–11–08; • US 8,071,746 issued 2011–12–06; • US 8,148,323 issued 2012–04–03; • US 8,835,378 issued 2014–09–16; • AU 2005295640 issued 2011–11–10; • CA 2584048 issued 2016–08–09; • EP 1812474 issued 2010–05–26, validated in CH, DE, ES, FR, GB and IT; and • JP 5,091,679 issued 2012–09–21. Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301–435–4507; thalhamc@mail.nih.gov. Collaborative Research Opportunity: The National Heart, Lung, and Blood Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize ApoA–1 mimetic peptides. For collaboration opportunities, please contact Denise Crooks, Ph.D. at 301–435–0103 or crooksd@nhlbi.nih.gov. Dated: November 30, 2016. Cristina Thalhammer-Reyero, Senior Licensing and Patenting Manager, Office of Technology Transfer and Development, National Heart, Lung, and Blood Institute. [FR Doc. 2016–29151 Filed 12–5–16; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 17:39 Dec 05, 2016 Jkt 241001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings 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 Child Health and Human Development Special Emphasis Panel; NICHD T35 Teleconference Review. Date: February 6, 2017. Time: 2:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge 6710B, 6701B Rockledge Drive, Bethesda, MD 20817 (Telephone Conference Call). Contact Person: Sherry L. Dupere, Ph.D., Chief, Scientific Review Branch, Scientific Review Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6710B Bethesda Drive, 2221A, Bethesda, MD 20892, 301– 451–3415, duperes@mail.nih.gov. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel; NICHD Consortium for Research on Pediatric Trauma and Injury Prevention (R24). Date: April 10, 2017. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW., Washington, DC 20015. Contact Person: Joanna Kubler-Kielb, Scientific Review Officer, Scientific Review Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Bethesda Drive, Bethesda, MD 20892, 301–435–6916, kielbj@ mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Dated: November 29, 2016. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–29140 Filed 12–5–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Accreditation and Approval of Camin Cargo Control, Inc., as a Commercial Gauger and Laboratory U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Notice of accreditation and approval of Camin Cargo Control, Inc., as a commercial gauger and laboratory. AGENCY: Notice is hereby given, pursuant to CBP regulations, that Camin Cargo Control, Inc., has been approved to gauge and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of June 7, 2016. DATES: Effective Dates: The accreditation and approval of Camin Cargo Control, Inc., as commercial gauger and laboratory became effective on June 7, 2016. The next triennial inspection date will be scheduled for June 2019. FOR FURTHER INFORMATION CONTACT: Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202– 344–1060. SUPPLEMENTARY INFORMATION: Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that Camin Cargo Control, Inc., 3001 SW. 3rd Ave., Suite #8, Fort Lauderdale, FL 33315, has been approved to gauge and accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. Camin Cargo Control, Inc., is approved for the following gauging procedures for petroleum and certain petroleum products set forth by the American Petroleum Institute (API): SUMMARY: API chapters 3 ................... 7 ................... 8 ................... 9 ................... 12 ................. 17 ................. E:\FR\FM\06DEN1.SGM 06DEN1 Title Tank gauging. Temperature Determination. Sampling. Density Determination. Calculations. Maritime Measurements.

Agencies

[Federal Register Volume 81, Number 234 (Tuesday, December 6, 2016)]
[Notices]
[Pages 87942-87943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29151]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Invention; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing in the U.S. to achieve 
expeditious commercialization of results of federally-funded research 
and development.

FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained 
by emailing the indicated licensing contact at the National Heart, 
Lung, and Blood, Office of Technology Transfer and Development Office 
of Technology Transfer, 31 Center Drive Room 4A29, MSC 2479, Bethesda, 
MD 20892-2479; telephone: 301-402-5579. A signed Confidential 
Disclosure Agreement may be required to receive any unpublished 
information.

SUPPLEMENTARY INFORMATION: Notice of Licensing of Government-Owned 
Inventions in accordance with 35 U.S.C. 209 and 37 CFR part 404. 
Technology description follows.

ApoA-1 Mimetic Peptides Promoting Lipid Efflux From Cells for Treatment 
of Vascular Disorders

    Description of Technology: This invention involves ApoA-1 mimetic 
peptides with multiple amphipathic alpha-helical domains that promote 
lipid efflux from cells and are useful in the treatment and prevention 
of dyslipidemic, inflammatory and vascular disorders. IND-enabling 
studies for one of the peptides, named Fx-5A, are completed in 
preparation for an IND filing at the FDA, to be followed by a Phase I 
clinical trial planned for 2017. Disorders amenable to treatment with 
the peptides include hyperlipidemia, hyperlipoproteinemia, 
hypercholesterolemia, HDL deficiency, hypertriglyceridemia, apoA-I 
deficiency, acute coronary syndrome, angina pectoris, aortic valve 
stenosis, atherosclerosis, carotid atherosclerosis, congestive heart 
failure, cerebral stroke, coronary artery disease, inflammation of the 
cardiovascular system, intermittent claudication, myocardial 
infarction, peripheral vascular disease, post-ischemic reperfusion, 
renal artery stenosis, reperfusion myocardial injury, restenosis, and 
thrombotic stroke.
    Potential Commercial Applications:
     Treatment and prevention of many hereditary, chronic and 
acute dyslipidemic and vascular disorders, where other treatments are 
not effective or too invasive, such as statins, partial ileal bypass 
surgery, portacaval shunt, liver transplantation, and removal of 
atherogenic lipoproteins by one of several apheresis procedures.
     Also applicable to the treatment of inflammation, asthma, 
colitis, inflammatory bowel disease (IBD), chronic kidney disease 
(CKD).
    Development Stage: Early-stage; In vitro data available; In vivo 
data available (animal)
    Inventors: Alan T. Remaley, Stephen J. Demosky, John A. Stonik, 
Marcelo J.A. Amar, Edward B. Neufeld, Fairwell Thomas, H. Bryan Brewer 
(all of NHLBI)

Publications:

1. Jin X, et al. ABCA1 (ATP-Binding Cassette Transporter A1) 
Mediates ApoA-I (Apolipoprotein A-I) and ApoA-I Mimetic Peptide 
Mobilization of Extracellular Cholesterol Microdomains Deposited by 
Macrophages. Arterioscler Thromb Vasc Biol. 2016 Dec;36(12):2283-
2291. [PMID 27758769]
2. Nowacki TM, et al. The 5A apolipoprotein A-I (apoA-I) mimetic 
peptide ameliorates experimental colitis by regulating monocyte 
infiltration. Br J Pharmacol. 2016 Sep;173(18):2780-92. [PMID 
27425846]
3. Yao X, et al. The A's Have It: Developing Apolipoprotein A-I 
Mimetic Peptides Into a Novel Treatment for Asthma. Chest. 2016 
Aug;150(2):283-8. [PMID 27327118]
4. Souza AC, et al. Antagonism of scavenger receptor CD36 by 5A 
peptide prevents chronic kidney disease progression in mice 
independent of blood pressure regulation. Kidney Int. 2016 
Apr;89(4):809-22. [PMID 26994575]
5. Schwendeman A, et al. The effect of phospholipid composition of 
reconstituted HDL on its cholesterol efflux and anti-inflammatory 
properties. J Lipid Res. 2015 Sep;56(9):1727-37. [PMID 26117661]
6. Sviridov DO, et al. Hydrophobic amino acids in the hinge region 
of the 5A apolipoprotein mimetic peptide are essential for promoting 
cholesterol efflux by the ABCA1 transporter. J Pharmacol Exp Ther. 
2013 Jan;344(1):50-8. [PMID 23042953]
7. Dai C, et al. Apolipoprotein A-I attenuates ovalbumin-induced 
neutrophilic airway inflammation via a granulocyte colony-

[[Page 87943]]

stimulating factor-dependent mechanism. Am J Respir Cell Mol Biol. 
2012 Aug;47(2):186-95. [PMID 22427535]
8. Yao X, et al. 5A, an apolipoprotein A-I mimetic peptide, 
attenuates the induction of house dust mite-induced asthma. J 
Immunol. 2011 Jan 1;186(1):576-83. [PMID 21115733]
9. Osei-Hwedieh DO, et al. Apolipoprotein mimetic peptides: 
Mechanisms of action as anti-atherogenic agents. Pharmacol Ther. 
2011 Apr;130(1):83-91. [PMID 21172387]
10. D'Souza W, et al. Structure/function relationships of 
apolipoprotein a-I mimetic peptides: implications for 
antiatherogenic activities of high-density lipoprotein. Circ Res. 
2010 Jul 23;107(2):217-27. [PMID 20508181]
11. Amar MJ, et al. 5A apolipoprotein mimetic peptide promotes 
cholesterol efflux and reduces atherosclerosis in mice. J Pharmacol 
Exp Ther. 2010 Aug;334(2):634-41. [PMID 20484557]
12. Tabet F, et al. The 5A apolipoprotein A-I mimetic peptide 
displays antiinflammatory and antioxidant properties in vivo and in 
vitro. Arterioscler Thromb Vasc Biol. 2010 Feb;30(2):246-52. [PMID 
19965776]
13. Sethi AA, et al. Asymmetry in the lipid affinity of bihelical 
amphipathic peptides. A structural determinant for the specificity 
of ABCA1-dependent cholesterol efflux by peptides. J Biol Chem. 2008 
Nov 21;283(47):32273-82. [PMID 18805791]

    Intellectual Property: NIH Reference No. E-114-2004/0--Issued 
Patents:

 US 7,572,771 issued 2009-11-08;
 US 8,071,746 issued 2011-12-06;
 US 8,148,323 issued 2012-04-03;
 US 8,835,378 issued 2014-09-16;
 AU 2005295640 issued 2011-11-10;
 CA 2584048 issued 2016-08-09;
 EP 1812474 issued 2010-05-26, validated in CH, DE, ES, FR, GB 
and IT; and
 JP 5,091,679 issued 2012-09-21.
    Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301-
435-4507; thalhamc@mail.nih.gov.
    Collaborative Research Opportunity: The National Heart, Lung, and 
Blood Institute is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate or commercialize ApoA-1 mimetic peptides. For collaboration 
opportunities, please contact Denise Crooks, Ph.D. at 301-435-0103 or 
crooksd@nhlbi.nih.gov.

    Dated: November 30, 2016.
Cristina Thalhammer-Reyero,
Senior Licensing and Patenting Manager, Office of Technology Transfer 
and Development, National Heart, Lung, and Blood Institute.
[FR Doc. 2016-29151 Filed 12-5-16; 8:45 am]
 BILLING CODE 4140-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.