81_FR_89719 81 FR 89481 - National Eye Institute; Notice of Meeting

81 FR 89481 - National Eye Institute; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 238 (December 12, 2016)

Page Range89481-89482
FR Document2016-29604

Federal Register, Volume 81 Issue 238 (Monday, December 12, 2016) 
[Federal Register Volume 81, Number 238 (Monday, December 12, 2016)]
[Notices]
[Pages 89481-89482]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-29604]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Eye Institute; 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 Eye Council.
    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 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 Advisory Eye Council.
    Date: January 19, 2017.
    Open: 8:30 a.m. to 1:00 p.m.
    Agenda: Following opening remarks by the Director, NEI, there 
will be presentations by the staff of the Institute and discussions 
concerning Institute programs.
    Place: Terrace Level Conference Rooms, 5635 Fishers Lane, 
Rockville, MD 20852.

[[Page 89482]]

    Closed: 1:00 p.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Terrace Level Conference Rooms, 5635 Fishers Lane, 
Rockville, MD 20852.
    Contact Person: Paul A. Sheehy, Ph.D., Director, Division of 
Extramural Affairs, National Eye Institute, National Institutes of 
Health, 5635 Fishers Lane, Suite 1300, Bethesda, MD 20892, 301-451-
2020, [email protected].

    Information is also available on the Institute's/Center's home 
page: www.nei.nih.gov, where an agenda and any additional 
information for the meeting will be posted when available.

(Catalogue of Federal Domestic Assistance Program Nos. 93.867, 
Vision Research, National Institutes of Health, HHS)

    Dated: December 6, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-29604 Filed 12-9-16; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 81, No. 238 / Monday, December 12, 2016 / Notices 89481 Liability immunity is afforded to Program (CICP) to provide benefits to Place: National Institutes of Health, 6701 manufacturers and distributors without certain individuals or estates of Rockledge Drive, Bethesda, MD 20892 regard to whether the countermeasure is individuals who sustain a covered (Telephone Conference Call) Contact Person: Ganesan Ramesh, Center used by or administered to this serious physical injury as the direct for Scientific Review, National Institutes of population; liability immunity is result of the administration or use of the Health, 6701 Rockledge Dr., Room 2182, MSC afforded to program planners and Covered Countermeasures, and benefits 7818, Bethesda, MD 20892, ganesan.ramesh@ qualified persons when the to certain survivors of individuals who nih.gov. countermeasure is used by or die as a direct result of the This notice is being published less than 15 administered to this population, or the administration or use of the Covered days prior to the meeting due to the timing program planner or qualified person Countermeasures. The causal limitations imposed by the review and reasonably could have believed the connection between the countermeasure funding cycle. recipient was in this population. and the serious physical injury must be (Catalogue of Federal Domestic Assistance supported by compelling, reliable, valid, Program Nos. 93.306, Comparative Medicine; XI. Geographic Area medical and scientific evidence in order 93.333, Clinical Research, 93.306, 93.333, 42 U.S.C. 247d–6d(a)(4), 247d– for the individual to be considered for 93.337, 93.393–93.396, 93.837–93.844, 6d(b)(2)(D) compensation. The CICP is 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) administered by the Health Resources Liability immunity is afforded for the Dated: December 6, 2016. and Services Administration, within the administration or use of a Covered Department of Health and Human Natasha M. Copeland, Countermeasure without geographic Services. Information about the CICP is Program Analyst, Office of Federal Advisory limitation. available by telephone at 855–266–2427 Committee Policy. Liability immunity is afforded to (toll-free) or http://www.hrsa.gov/cicp/. [FR Doc. 2016–29603 Filed 12–9–16; 8:45 am] manufacturers and distributors without regard to whether the countermeasure is BILLING CODE 4140–01–P XV. Amendments used by or administered in any 42 U.S.C. 247d–6d(b)(4) designated geographic area; liability Any amendments to this Declaration DEPARTMENT OF HEALTH AND immunity is afforded to program will be published in the Federal HUMAN SERVICES planners and qualified persons when the countermeasure is used by or Register. National Institutes of Health administered in any designated Authority: 42 U.S.C. 247d–6d. geographic area, or the program planner Dated: December 2, 2016. National Eye Institute; Notice of or qualified person reasonably could Sylvia M. Burwell, Meeting have believed the recipient was in that Secretary, Department of Health and Human Pursuant to section 10(d) of the geographic area. Services. Federal Advisory Committee Act, as XII. Effective Time Period [FR Doc. 2016–29609 Filed 12–9–16; 8:45 am] amended (5 U.S.C. App.), notice is 42 U.S.C. 247d–6d(b)(2)(B) BILLING CODE 4150–28–P hereby given of a meeting of the National Advisory Eye Council. Liability immunity for Covered The meeting will be open to the Countermeasures began on February 27, DEPARTMENT OF HEALTH AND public as indicated below, with 2015, and extends through February 26, HUMAN SERVICES attendance limited to space available. 2019. Individuals who plan to attend and National Institutes of Health XIII. Additional Time Period of need special assistance, such as sign Coverage Center for Scientific Review; Notice of language interpretation or other Closed Meeting reasonable accommodations, should 42 U.S.C. 247d–6d(b)(3)(B) and (C) notify the Contact Person listed below I have determined that an additional Pursuant to section 10(d) of the in advance of the meeting. 12 months of liability protection is Federal Advisory Committee Act, as The meeting will be closed to the reasonable to allow for the amended (5 U.S.C. App.), notice is public in accordance with the manufacturer(s) to arrange for hereby given of the following meeting. provisions set forth in sections disposition of the Covered The meeting will be closed to the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Countermeasure, including return of the public in accordance with the as amended. The grant applications and Covered Countermeasures to the provisions set forth in sections the discussions could disclose manufacturer, and for Covered Persons 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., confidential trade secrets or commercial to take such other actions as are as amended. The grant applications and property such as patentable material, appropriate to limit the administration the discussions could disclose and personal information concerning or use of the Covered Countermeasures. confidential trade secrets or commercial individuals associated with the grant Covered Countermeasures obtained property such as patentable material, applications, the disclosure of which for the SNS during the effective period and personal information concerning would constitute a clearly unwarranted of this Declaration are covered through individuals associated with the grant invasion of personal privacy. the date of administration or use applications, the disclosure of which Name of Committee: National Advisory pursuant to a distribution or release would constitute a clearly unwarranted Eye Council. mstockstill on DSK3G9T082PROD with NOTICES from the SNS. invasion of personal privacy. Date: January 19, 2017. Name of Committee: Center for Scientific Open: 8:30 a.m. to 1:00 p.m. XIV. Countermeasures Injury Review Special Emphasis Panel; Agenda: Following opening remarks by the Compensation Program Neurogastroenterology. Director, NEI, there will be presentations by 42 U.S.C 247d–6e Date: December 14, 2016. the staff of the Institute and discussions Time: 9:00 a.m. to 10:00 a.m. concerning Institute programs. The PREP Act authorizes the Agenda: To review and evaluate grant Place: Terrace Level Conference Rooms, Countermeasures Injury Compensation applications. 5635 Fishers Lane, Rockville, MD 20852. VerDate Sep<11>2014 20:00 Dec 09, 2016 Jkt 241001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1

89482 Federal Register / Vol. 81, No. 238 / Monday, December 12, 2016 / Notices Closed: 1:00 p.m. to 5:00 p.m. strongly linked to neurological Adrian Creanga (NIAID), Julie Agenda: To review and evaluate grant complications including Guillain-Barré Ledgerwood (NIAID), William Schief applications. syndrome, meningoencephalitis, and (The Scripps Research Institute), Place: Terrace Level Conference Rooms, microcephaly. The association between Sebastian Ramisch (The Scripps 5635 Fishers Lane, Rockville, MD 20852. Contact Person: Paul A. Sheehy, Ph.D., active ZIKV infection during pregnancy Research Institute), Leda Castilho Director, Division of Extramural Affairs, and microcephaly and intrauterine (Federal University of Rio de Janeiro) National Eye Institute, National Institutes of growth retardation in the fetus has been Publications: K.A. Dowd, et al., Health, 5635 Fishers Lane, Suite 1300, confirmed in murine models of ZIKV Science, 354, 237–240 (2016). Bethesda, MD 20892, 301–451–2020, ps32h@ infection. DOI: 10.1126/science.aai9137. nih.gov. Scientists at NIAID have developed Intellectual Property: U.S. Patent Information is also available on the nucleic acid-based vaccine candidates Application No. 62/396,613 filed Institute’s/Center’s home page: to prevent ZIKV infection in humans. September 19, 2016 (HHS Reference No. www.nei.nih.gov, where an agenda and any The current lead candidate vaccine is a E–181–2016/0–US–01). additional information for the meeting will Licensing Contact: Dr. Amy Petrik, plasmid DNA vaccine demonstrated to be posted when available. 240–627–3721; amy.petrik@nih.gov. accord protection in preclinical models (Catalogue of Federal Domestic Assistance Collaborative Research Opportunity: Program Nos. 93.867, Vision Research, and is undergoing clinical trial evaluation. Nucleic acid-based vaccines The National Institute of Allergy and National Institutes of Health, HHS) Infectious Diseases is seeking statements have been developed previously for Dated: December 6, 2016. West Nile virus, another flavivirus of capability or interest from parties Natasha M. Copeland, similar to Zika (J.E. Ledgerwood, et al. interested in collaborative research to Program Analyst, Office of Federal Advisory J. Infect. Dis. (2011) 203 (10): 1396– further develop, evaluate or Committee Policy. 1404). Immunization with the nucleic commercialize Zika virus vaccine [FR Doc. 2016–29604 Filed 12–9–16; 8:45 am] acid ZIKV vaccine candidate results in technologies. For collaboration BILLING CODE 4140–01–P production of noninfectious virus like opportunities, please contact Dr. Amy particles (VLPs) made of ZIKV proteins. Petrik, 240–627–3721; amy.petrik@ These ZIKV VLPs elicit an immune nih.gov. DEPARTMENT OF HEALTH AND response which includes neutralizing Dated: December 5, 2016. HUMAN SERVICES antibodies to ZIKV. Suzanne Frisbie, Other preclinical ZIKV vaccine Deputy Director, Technology Transfer and National Institutes of Health candidates include mRNA, protein, and Intellectual Property Office, National Institute Government-Owned Inventions; noninfectious VLPs. of Allergy and Infectious Diseases. Availability for Licensing NIAID is continuing development of [FR Doc. 2016–29605 Filed 12–9–16; 8:45 am] these vaccine candidates. The DNA- BILLING CODE 4140–01–P AGENCY: National Institutes of Health, based ZIKV vaccine candidate is HHS. currently in clinical trials. ACTION: Notice. Consequently, for some fields of use, DEPARTMENT OF HOMELAND NIAID will evaluate a license SECURITY SUMMARY: The invention listed below is applicant’s capabilities and experience owned by an agency of the U.S. in advancing similar technologies U.S. Customs And Border Protection Government and is available for through the regulatory process. licensing to achieve expeditious This technology is available for Modification and Clarification of the commercialization of results of licensing for commercial development National Customs Automation federally-funded research and in accordance with 35 U.S.C. 209 and 37 Program Tests Regarding Post- development. Foreign patent CFR part 404, as well as for further Summary Corrections and Periodic applications are filed on selected development and evaluation under a Monthly Statements inventions to extend market coverage research collaboration. This technology for companies and may also be available AGENCY: U.S. Customs and Border is not eligible for NIH’s start up license. for licensing. Protection, Department of Homeland Potential Commercial Applications: Security. FOR FURTHER INFORMATION CONTACT: • Prevention of Zika virus infection Licensing information and copies of the ACTION: General notice. Competitive Advantages: U.S. patent application listed below • There is currently no licensed Zika SUMMARY: This document announces may be obtained by communicating virus vaccine U.S. Customs and Border Protection’s with the indicated licensing contact at Development Stage: (CBP’s) plan to modify and clarify the the Technology Transfer and • Currently, DNA-based vaccine National Customs Automation Program Intellectual Property Office, National candidate in Phase I clinical trial (NCAP) test pertaining to the processing Institute of Allergy and Infectious • Phase II clinical trial planned for of post-summary correction (PSC) Diseases, 5601 Fishers Lane, Rockville, early 2017 for DNA-based vaccine claims to entry summaries that are filed MD 20852; tel. 301–496–2644. A signed candidate in the Automated Commercial Confidential Disclosure Agreement will • Other candidates are in pre-clinical Environment (ACE), as well as the be required to receive copies of development periodic monthly statement (PMS) test. unpublished patent applications. Inventors: Barney S. Graham (NIAID), The modifications made by this notice mstockstill on DSK3G9T082PROD with NOTICES SUPPLEMENTARY INFORMATION: Theodore C. Pierson (NIAID), Kimberly eliminate some requirements and Technology description follows. A. Dowd (NIAID), John R. Mascola liberalize certain requirements needed Zika Virus Vaccines (NIAID), Wing-Pui Kong (NIAID), Sung- for the filing of a PSC making it easier Youl Ko (NIAID), Eun Sung Yang for importers to file a PSC for additional Description of Technology (NIAID), Wei Shi (NIAID), Lingshu entry types, and allowing for additional Zika virus (ZIKV) is a flavivirus Wang (NIAID), Christina R. Demaso time to make a deposit for duties, fees transmitted by mosquitos that is (NIAID), Rebecca S. Pelc (NIAID), and taxes owed. With regard to the PMS VerDate Sep<11>2014 18:59 Dec 09, 2016 Jkt 241001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1


Document Created: 2018-02-14 09:05:24
Document Modified: 2018-02-14 09:05:24
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
DatesJanuary 19, 2017.
FR Citation81 FR 89481 
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