81_FR_52851 81 FR 52698 - National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings

81 FR 52698 - National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 153 (August 9, 2016)

Page Range52698-52699
FR Document2016-18863

Federal Register, Volume 81 Issue 153 (Tuesday, August 9, 2016) 
[Federal Register Volume 81, Number 153 (Tuesday, August 9, 2016)]
[Notices]
[Pages 52698-52699]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18863]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Neurological Disorders and Stroke; 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 Neurological Disorders 
and Stroke Special Emphasis Panel; Review of Late Arriving K 
Mechanism Grant Applications.
    Date: August 17, 2016.
    Time: 8:00 a.m. to 11:00 a.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Neuroscience Center, 6001 
Executive Boulevard, Rockville, MD 20852 (Telephone Conference 
Call).

[[Page 52699]]

    Contact Person: William C. Benzing, Ph.D., Scientific Review 
Officer, Scientific Review Branch, Division of Extramural Research, 
NINDS/ NIH/DHHS, Neuroscience Center, 6001 Executive Blvd., Suite 
3204, MSC 9529, Bethesda, MD 20892-9529, 301-496-0660, 
Benzingw@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.

    Name of Committee: National Institute of Neurological Disorders 
and Stroke Special Emphasis Panel; Clinician Training Program R25 
Application Review.
    Date: August 17, 2016.
    Time: 2:00 p.m. to 8:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Neuroscience Center, 6001 
Executive Boulevard, Rockville, MD 20852 (Telephone Conference 
Call).
    Contact Person: William C. Benzing, Ph.D., Scientific Review 
Officer, Scientific Review Branch, Division of Extramural Research, 
NINDS/NIH/DHHS, Neuroscience Center, 6001 Executive Blvd, Suite MSC 
9529, Bethesda, MD 20892-9529, 301-496-0660, Benzingw@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.

    Name of Committee: National Institute of Neurological Disorders 
and Stroke Special Emphasis Panel; Biorepository Resource Access 
Committee (BRAC) X01 Meeting.
    Date: August 18, 2016.
    Time: 1:00 p.m. to 3:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Neuroscience Center, 6001 
Executive Boulevard, Rockville, MD 20852 (Telephone Conference 
Call).
    Contact Person: Joel A. Sayoff, Ph.D., Scientific Review 
Officer, Scientific Review Branch, Division of Extramural Research, 
NINDS/NIH/DHHS, Neuroscience Center, 6001 Executive Blvd., Suite 
3204, MSC 9529, Bethesda, MD 20892-9529, 301-496-9223, 
joel.saydoff@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. 93.853, 
Clinical Research Related to Neurological Disorders; 93.854, 
Biological Basis Research in the Neurosciences, National Institutes 
of Health, HHS)

    Dated: August 3, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-18863 Filed 8-8-16; 8:45 am]
 BILLING CODE 4140-01-P

52698 Federal Register / Vol. 81, No. 153 / Tuesday, August 9, 2016 / Notices SUMMARY: The invention listed below is can provide a robust immune response response using Conserved Element owned by an agency of the U.S. compared to administration of a full- Constructs. Government and is available for length Env or Gag protein. The Env-CE Publications licensing and/or co-development in the DNA vaccines were tested in a rhesus U.S. in accordance with 35 U.S.C. 209 macaque model and were able to induce • Kulkarni, V. et al. PLoS One;9:e86254. 2014. http://journals.plos.org/plosone/ and 37 CFR part 404 to achieve a cellular and humoral immune article?id=10.1371/journal.pone.0086254 expeditious commercialization of response in this model whereas • Kulkarni, V. et al. PLos One Oct results of federally-funded research and vaccination with the full length DNA 22;9(10):e111085. doi: 10.1371/ development. Foreign patent did not produce the same effect. journal.pone.0111085. eCollection, 2014. applications are filed on selected A robust increase in immunity was http://journals.plos.org/plosone/ inventions to extend market coverage observed when rhesus macaques were article?id=10.1371/journal.pone.0111085 for companies and may also be available subjected to a prime-boost protocol. Related Technologies: HHS Reference for licensing and/or co-development. First, rhesus macaques were primed #E–132–2012/0 Method of Altering the ADDRESSES: Invention Development and with Env-CE DNA and boosted with full Immunodominance Hierarchy of HIV Marketing Unit, Technology Transfer length Env resulting in an observed Gag by DNA Vaccine Expressing Center, National Cancer Institute, 9609 increase in both the cellular and Conserved Regions. Medical Center Drive, Mail Stop 9702, humoral responses. A further increase Contact Information: Requests for Rockville, MD 20850–9702. in immune response was observed from copies of the patent application or FOR FURTHER INFORMATION CONTACT: priming with CE and boosting with a inquiries about licensing, research Information on licensing and co- combination of CE and full length DNA collaborations, and co-development development research collaborations, resulting in a significantly improved opportunities should be sent to John D. and copies of the U.S. patent breadth of immune responses. These Hewes, Ph.D., email: john.hewes@ applications listed below may be improved protocols may help solve the nih.gov. obtained by contacting: Attn. Invention immunodominance problem observed in current protocols. This is considered Dated: August 2, 2016. Development and Marketing Unit, a major obstacle for HIV vaccine John D. Hewes, Technology Transfer Center, National development. The CE vaccines Technology Transfer Specialist, Technology Cancer Institute, 9609 Medical Center described by this invention have Transfer Center, National Cancer Institute. Drive, Mail Stop 9702, Rockville, MD potential for use as prophylactic and [FR Doc. 2016–18861 Filed 8–8–16; 8:45 am] 20850–9702, Tel. 240–276–5515 or email ncitechtransfer@mail.nih.gov. A therapeutic HIV vaccines. BILLING CODE 4140–01–P signed Confidential Disclosure Potential Commercial Applications: Agreement may be required to receive • HIV vaccines Value Proposition: DEPARTMENT OF HEALTH AND copies of the patent applications. • Addresses two key hurdles faced by HUMAN SERVICES SUPPLEMENTARY INFORMATION: Technology description follows. current HIV vaccines: sequence National Institutes of Health Title of invention: Vaccines for HIV. diversity of HIV and Description of Technology: Although immunodominance. National Institute of Neurological the development of an effective HIV • Induces cross-clade specific Disorders and Stroke; Notice of Closed vaccine has been an ongoing area of immune response. Meetings research, the high variability in HIV–1 • The prime-boost immunization virus strains has represented a major regimen is not limited to HIV, but can Pursuant to section 10(d) of the challenge in successful development. be employed to improve the induction Federal Advisory Committee Act, as Ideally, an effective candidate vaccine of immune responses to any amended (5 U.S.C. App.), notice is would provide protection against the subdominant epitopes (cellular or hereby given of the following meetings. majority of clades of HIV. Two major humoral) to increase breadth, magnitude The meetings will be closed to the challenges are immunodominance and and quality of the immune response. public in accordance with the sequence diversity. One strategy for Development Stage: Pre-clinical (in provisions set forth in sections overcoming these two issues is to vivo validation). 552b(c)(4) and 552b(c)(6), title 5 U.S.C., identify the conserved regions of the Inventor(s): George Pavlakis, Barbara as amended. The grant applications and virus and exploit them for use in a Felber, Antonio Valentin, James the discussions could disclose targeted therapy. Mullins. confidential trade secrets or commercial Researchers at the National Cancer Intellectual Property: HHS Reference property such as patentable material, Institute’s Vaccine Branch used #E–087–2015/0–US–01, corresponding and personal information concerning conserved elements (CEs) of the to U.S. Provisional Patent App. #62/ individuals associated with the grant polypeptides Gag and Env as 161,123, filed on May 13, 2015, entitled: applications, the disclosure of which immunogenic compositions to induce HIV Env Conserved Element DNA would constitute a clearly unwarranted an immune response to HIV–1 envelope Vaccine. invasion of personal privacy. polypeptides and Gag polypeptides. HHS Reference #E–009–2016/0–US– Name of Committee: National Institute of conserved elements (CEs) of the 01, corresponding to U.S. Provisional Neurological Disorders and Stroke Special polypeptides Gag and Env as Patent App. #62/241,599, filed on Emphasis Panel; Review of Late Arriving K asabaliauskas on DSK3SPTVN1PROD with NOTICES immunogenic compositions to induce October 14, 2015, entitled: Prime-Boost Mechanism Grant Applications. an immune response to HIV–1 envelope combination vaccine to Expand Breadth Date: August 17, 2016. polypeptides and Gag polypeptides. of Immunological Response. Time: 8:00 a.m. to 11:00 a.m. Agenda: To review and evaluate grant This invention is based, in part, on the HHS Reference #E–087–2015/0–PCT– applications. discovery that administration of one or 02; corresponding to International Place: National Institutes of Health, more polypeptides comprising CEs, Patent App. #PCT/US2016/032317; filed Neuroscience Center, 6001 Executive separated by linkers and collinearly on May 13, 2016, entitled: Methods and Boulevard, Rockville, MD 20852 (Telephone arranged, of HIV Env or Gag CE proteins Compositions for inducing an immune Conference Call). VerDate Sep<11>2014 20:00 Aug 08, 2016 Jkt 238001 PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 E:\FR\FM\09AUN1.SGM 09AUN1

Federal Register / Vol. 81, No. 153 / Tuesday, August 9, 2016 / Notices 52699 Contact Person: William C. Benzing, Ph.D., DEPARTMENT OF HEALTH AND The technology is directed to methods Scientific Review Officer, Scientific Review HUMAN SERVICES of treating diseases characterized by Branch, Division of Extramural Research, demyelination (such as Multiple NINDS/ NIH/DHHS, Neuroscience Center, National Institutes of Health sclerosis), white matter injury, or 6001 Executive Blvd., Suite 3204, MSC 9529, conditions associated with myelin Bethesda, MD 20892–9529, 301–496–0660, Government-Owned Inventions; remodeling by administering an agent Benzingw@mail.nih.gov. Availability for Licensing that inhibits cleavage of Neurofascin This notice is being published less than 15 155 or Caspr1. The agent could be a days prior to the meeting due to the timing AGENCY: National Institutes of Health, HHS. thrombin inhibitor, an agent that limitations imposed by the review and inhibits thrombin expression, an anti- funding cycle. ACTION: Notice thrombin antibody that specifically Name of Committee: National Institute of inhibits thrombin mediated cleavage of Neurological Disorders and Stroke Special SUMMARY: The invention listed below is owned by an agency of the U.S. Neurofascin 155, a mutated version or Emphasis Panel; Clinician Training Program fragment of Neurofascin 155 or Caspr1, R25 Application Review. Government and is available for licensing and/or co-development in the antibodies to Neurofascin 155 or Caspr1. Date: August 17, 2016. The technology also includes methods Time: 2:00 p.m. to 8:00 p.m. U.S. in accordance with 35 U.S.C. 209 of detecting remodeling of myelin by Agenda: To review and evaluate grant and 37 CFR part 404 to achieve detecting changes in levels of applications. expeditious commercialization of Neurofascin 125 and Neurofascin 30 in Place: National Institutes of Health, results of federally-funded research and a biological sample, such as central Neuroscience Center, 6001 Executive development. Foreign patent spinal fluid or blood. Boulevard, Rockville, MD 20852 (Telephone applications are filed on selected Potential Commercial Applications: Conference Call). inventions to extend market coverage Treatment of demyelinating diseases, Contact Person: William C. Benzing, Ph.D., for companies and may also be available such as Multiple sclerosis. Scientific Review Officer, Scientific Review for licensing and/or co-development. Treatment of diseases characterized Branch, Division of Extramural Research, ADDRESSES: Invention Development and by white matter injury or myelin NINDS/NIH/DHHS, Neuroscience Center, Marketing Unit, Technology Transfer remodeling. 6001 Executive Blvd, Suite MSC 9529, Center, National Cancer Institute, 9609 Monitoring the amount of or rate of Bethesda, MD 20892–9529, 301–496–0660, Medical Center Drive, Mail Stop 9702, remodeling of myelin to determine the Benzingw@mail.nih.gov. Rockville, MD, 20850–9702. efficacy of agents used demyelinating This notice is being published less than 15 days prior to the meeting due to the timing FOR FURTHER INFORMATION CONTACT: diseases. Information on licensing and co- Value Proposition: Agents which limitations imposed by the review and development research collaborations, inhibit cleavage of Neurofascin 155 or funding cycle. and copies of the U.S. patent Caspr1 or inhibit thrombin activity are Name of Committee: National Institute of a novel approach to treating Neurological Disorders and Stroke Special applications listed below may be obtained by contacting: Attn. Invention demyelinating diseases or diseases Emphasis Panel; Biorepository Resource Development and Marketing Unit, characterized by white matter injury. Access Committee (BRAC) X01 Meeting. Technology Transfer Center, National The methods of detecting Date: August 18, 2016. Cancer Institute, 9609 Medical Center modification in the amount or rate of Time: 1:00 p.m. to 3:00 p.m. Drive, Mail Stop 9702, Rockville, MD, remodeling of myelin can be used to Agenda: To review and evaluate grant applications. 20850–9702, Tel. 240–276–5515 or determine the efficacy of treatments of Place: National Institutes of Health, email ncitechtransfer@mail.nih.gov. A neurological disorders and are less Neuroscience Center, 6001 Executive signed Confidential Disclosure expensive than other methods currently Boulevard, Rockville, MD 20852 (Telephone Agreement may be required to receive used. Conference Call). copies of the patent applications. Development Stage: Pre-clinical (in Contact Person: Joel A. Sayoff, Ph.D., vivo validation). SUPPLEMENTARY INFORMATION: Inventor(s): R. Douglas Fields https:// Scientific Review Officer, Scientific Review Technology description follows. Branch, Division of Extramural Research, science.nichd.nih.gov/confluence/ Title of invention: Methods of display/snsdp/Home. NINDS/NIH/DHHS, Neuroscience Center, Treating or Preventing Demyelination Intellectual Property: HHS Reference 6001 Executive Blvd., Suite 3204, MSC 9529, Bethesda, MD 20892–9529, 301–496–9223, Using Thrombin Inhibitors and Methods No. E–151–2015/0–PCT–02. joel.saydoff@nih.gov. of Detecting Demyelination Using PCT application, PCT/US2016/ This notice is being published less than 15 Neurofascin 155. 027776, filed April 15, 2016 entitled days prior to the meeting due to the timing Description of Technology: ‘‘Methods of Treating or Preventing limitations imposed by the review and Neurofascin 155 is a cell adhesion Demyelination Using Thrombin funding cycle. molecule that attaches myelin to Inhibitors and Methods of Detecting (Catalogue of Federal Domestic Assistance axolemma. Contactin-associated protein Demyelination Using Neurofascin 155’’. Program Nos. 93.853, Clinical Research (Caspr) is a major component of the Publications: 1. In preparation. Related to Neurological Disorders; 93.854, perinodes. Perinodal astrocytes regulate Collaboration Opportunity: Biological Basis Research in the nodal structure and myelin thickness by Researchers at the Eunice Kennedy regulating thrombin-dependent cleavage Shriver National Institute of Child asabaliauskas on DSK3SPTVN1PROD with NOTICES Neurosciences, National Institutes of Health, HHS) of axo-glial junction attaching the Health and Human Development outermost paranodal loops of myelin to (‘‘NICHD’’), seek CRADA partner or Dated: August 3, 2016. the axon membrane. Agents which collaboration for development of agents Sylvia L. Neal, inhibit the cleavage of Neurofascin 155 to treat multiple sclerosis or other Program Analyst, Office of Federal Advisory or the cleavage of Caspr1 stabilize the conditions associated with myelin Committee Policy. node and may impede the remodeling by administering an agent [FR Doc. 2016–18863 Filed 8–8–16; 8:45 am] immunological attack of myelin where that inhibits cleavage of Neurofascin BILLING CODE 4140–01–P the paranodes are attached to the axon. 155 or Caspr1. The agent could be a VerDate Sep<11>2014 20:00 Aug 08, 2016 Jkt 238001 PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 E:\FR\FM\09AUN1.SGM 09AUN1


Document Created: 2016-08-09 01:10:19
Document Modified: 2016-08-09 01:10:19
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesAugust 17, 2016.
FR Citation81 FR 52698 
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