Prospective Grant of Start-Up Exclusive License: Therapeutics for Frontotemporal Dementia, Alzheimer's Disease Excluding Intranasal Delivery, Neuronal Injury (Stroke, Traumatic Brain Injury (TBI) and Epilepsy), and Progressive Supranuclear Palsy, 65662-65663 [2016-22897]

Download as PDF 65662 Federal Register / Vol. 81, No. 185 / Friday, September 23, 2016 / Notices 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 Allergy and Infectious Diseases Special Emphasis Panel; Rapid Assessment of Zika Virus (ZIKV) Complications (R21). Date: October 18–19, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call). Contact Person: Raymond R. Schleef, Ph.D., Senior Scientific Review, Officer Scientific Review Program, Division of Extramural Activities, Room 3E61, National Institutes of Health/NIAID, 5601 Fishers Lane, MSC 9823, Bethesda, MD 20892–9823, (240) 669–5019, schleefrr@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: September 19, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–22899 Filed 9–22–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute; Notice of Closed Meeting sradovich on DSK3GMQ082PROD 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 Eye Institute Special Emphasis Panel; NEI Clinical and Epidemiological grant applications (Cooperative Agreements and RPGs). Date: October 19, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate cooperative agreement applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. VerDate Sep<11>2014 18:22 Sep 22, 2016 Jkt 238001 Contact Person: Jeanette M. Hosseini, Ph.D., Scientific Review Officer, 5635 Fishers Lane, Suite 1300, Bethesda, MD 20892, 301– 451–2020, jeanetteh@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.867, Vision Research, National Institutes of Health, HHS) Dated: September 19, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–22898 Filed 9–22–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; 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 General Medical Sciences Special Emphasis Panel; Review of SCORE Applications. Date: October 27–28, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: The St. Regis, Washington DC, 923 16th and K Street NW., Washington, DC 20006. Contact Person: John J. Laffan, Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, Natcher Building, Room 3AN18J, Bethesda, MD 20892, 301–594–2773, laffanjo@mail.nih.gov. Name of Committee: National Institute of General Medical Sciences Special Emphasis Panel; Review of MIRA Applications. Date: November 3–4, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Garden Inn DC/Bethesda, 7301 Waverly Street, Bethesda, MD 20814. Contact Person: Saraswathy Seetharam, Ph.D., Scientific Review Officer, Office Scientific Review, National Institute of General Medical Sciences, National Institutes Health, 45 Center Drive, Room 3AN12C, Bethesda, MD 20892, 301–594–2763, seetharams@nigms.nih.gov. PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research; Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) Dated: September 19, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–22900 Filed 9–22–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Start-Up Exclusive License: Therapeutics for Frontotemporal Dementia, Alzheimer’s Disease Excluding Intranasal Delivery, Neuronal Injury (Stroke, Traumatic Brain Injury (TBI) and Epilepsy), and Progressive Supranuclear Palsy AGENCY: National Institutes of Health, HHS. ACTION: Notice. This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a start-up exclusive license to Cogentis Therapeutics, Inc. which is located in Maryland, to practice the inventions embodied in the following patents: U.S. Patent 8,597,660, issued December 3, 2013 (HHS reference E–144–2010/0– US–02). The patent rights in these inventions have been assigned to the United States of America. The prospective start-up exclusive license territory may be worldwide and the field of use may be limited to Frontotemporal dementia, Alzheimer’s disease excluding intranasal delivery, Neuronal injury (stroke, traumatic brain injury (TBI) and epilepsy), and Progressive Supranuclear Palsy. DATES: Only written comments and/or applications for a license which are received by NINDS Technology Transfer on or before October 11, 2016 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated start-up exclusive license SUMMARY: E:\FR\FM\23SEN1.SGM 23SEN1 Federal Register / Vol. 81, No. 185 / Friday, September 23, 2016 / Notices should be directed to: Susan Ano, Ph.D., NINDS Technology Transfer, 31 Center Drive, Suite 8A52, MS2540, Bethesda, MD 20892; Telephone: (301) 435–5515; Email: anos@mail.nih.gov. SUPPLEMENTARY INFORMATION: [FR Doc. 2016–22897 Filed 9–22–16; 8:45 am] This sradovich on DSK3GMQ082PROD with NOTICES invention discloses treating neurodegenerative diseases by administering cyclin dependent kinase 5 (Cdk5) inhibitory peptides derived from P35, the activator of Cdk5. Abnormally hyperactive Cdk5 has been shown to be associated with a variety of neurodegenerative disorders. This invention describes isolated peptide fragments, pharmaceutical compositions and methods for use of such for treating subjects with a neurodegenerative disease, such as Alzheimer’s disease (AD), Amyotrophic Lateral Sclerosis (ALS) and Parkinson’s disease (PD). An inhibitory fragment, TFP5, disclosed in this invention, has been shown to ameliorate symptoms of AD in disease animal models without any evidence of toxicity. In particular, TFP5 treatment of rat cortical neurons reduced hyperactivation of Cdk5 upon neuronal stress and insults. Following intraperitoneal (ip) injection, TFP5 was capable of crossing the blood-brain barrier and localizing within the brain where it was found to rescue memory deficits and pathology in a double transgenic mouse (APP/PS1) AD model. The prospective start-up exclusive license may be granted unless within fifteen (15) 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 part 404. Complete applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated start-up 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. VerDate Sep<11>2014 18:22 Sep 22, 2016 Jkt 238001 Dated: September 19, 2016. Susan Ano, Technology Development Coordinator, NINDS Technology Transfer, National Institutes of Health. BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; Palliative Care: Conversations Matter® Phase Two Evaluation (National Institute of Nursing Research) National Institutes of Health, Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on July 12, 2016, page 45169 (81 FR 45169) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. DATES: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. ADDRESSES: 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: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to (202) 395–6974, Attention: Desk Officer for NIH. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Ms. Diana Finegold, Office of Communications and Public Liaison, NINR, NIH, Building 31, SUMMARY: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 65663 Suite 5B03, 31 Center Drive, Bethesda, MD 20892, or call non-toll-free number (301) 496–0209, or Email your request, including your address to: Diana.Finegold@nih.gov. SUPPLEMENTARY INFORMATION: The National Institute of Nursing Research (NINR), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. Proposed Collection: Palliative Care: Conversations Matter® Phase Two Evaluation, 0925–0683, National Institute of Nursing Research (NINR), National Institutes of Health (NIH). Need and Use of Information Collection: The NINR Palliative Care: Conversations Matter® initiative, which launched in FY 2014, is now in its second phase. The first phase was focused on providing materials and tools to assist health care providers in having sometimes difficult conversations with children and families about palliative care. The second phase of the campaign, launched in FY 2015, focuses on children, parents, and families. The Palliative Care: Conversations Matter® Phase Two evaluation will assess the information and materials being disseminated to children, parents, and families. Survey findings will help (1) determine if the campaign is effective, relevant, and useful to the families and caregivers of children living with serious illnesses; (2) to better understand the information needs of families and caregivers to inform future campaign efforts; and (3) examine how effective the campaign materials are in providing families and caregivers with information on palliative care. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 371 hours. E:\FR\FM\23SEN1.SGM 23SEN1

Agencies

[Federal Register Volume 81, Number 185 (Friday, September 23, 2016)]
[Notices]
[Pages 65662-65663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22897]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Start-Up Exclusive License: Therapeutics for 
Frontotemporal Dementia, Alzheimer's Disease Excluding Intranasal 
Delivery, Neuronal Injury (Stroke, Traumatic Brain Injury (TBI) and 
Epilepsy), and Progressive Supranuclear Palsy

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Institute of Neurological Disorders and 
Stroke (NINDS), National Institutes of Health (NIH), Department of 
Health and Human Services, is contemplating the grant of a start-up 
exclusive license to Cogentis Therapeutics, Inc. which is located in 
Maryland, to practice the inventions embodied in the following patents: 
U.S. Patent 8,597,660, issued December 3, 2013 (HHS reference E-144-
2010/0-US-02).
    The patent rights in these inventions have been assigned to the 
United States of America. The prospective start-up exclusive license 
territory may be worldwide and the field of use may be limited to 
Frontotemporal dementia, Alzheimer's disease excluding intranasal 
delivery, Neuronal injury (stroke, traumatic brain injury (TBI) and 
epilepsy), and Progressive Supranuclear Palsy.

DATES: Only written comments and/or applications for a license which 
are received by NINDS Technology Transfer on or before October 11, 2016 
will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated start-up 
exclusive license

[[Page 65663]]

should be directed to: Susan Ano, Ph.D., NINDS Technology Transfer, 31 
Center Drive, Suite 8A52, MS2540, Bethesda, MD 20892; Telephone: (301) 
435-5515; Email: anos@mail.nih.gov.

SUPPLEMENTARY INFORMATION: This invention discloses treating 
neurodegenerative diseases by administering cyclin dependent kinase 5 
(Cdk5) inhibitory peptides derived from P35, the activator of Cdk5. 
Abnormally hyperactive Cdk5 has been shown to be associated with a 
variety of neurodegenerative disorders. This invention describes 
isolated peptide fragments, pharmaceutical compositions and methods for 
use of such for treating subjects with a neurodegenerative disease, 
such as Alzheimer's disease (AD), Amyotrophic Lateral Sclerosis (ALS) 
and Parkinson's disease (PD). An inhibitory fragment, TFP5, disclosed 
in this invention, has been shown to ameliorate symptoms of AD in 
disease animal models without any evidence of toxicity. In particular, 
TFP5 treatment of rat cortical neurons reduced hyperactivation of Cdk5 
upon neuronal stress and insults. Following intraperitoneal (ip) 
injection, TFP5 was capable of crossing the blood-brain barrier and 
localizing within the brain where it was found to rescue memory 
deficits and pathology in a double transgenic mouse (APP/PS1) AD model.
    The prospective start-up exclusive license may be granted unless 
within fifteen (15) 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 part 404.
    Complete applications for a license in the field of use filed in 
response to this notice will be treated as objections to the grant of 
the contemplated start-up 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: September 19, 2016.
Susan Ano,
Technology Development Coordinator, NINDS Technology Transfer, National 
Institutes of Health.
[FR Doc. 2016-22897 Filed 9-22-16; 8:45 am]
 BILLING CODE 4140-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.