Meeting of the National Clinical Care Commission, 50665-50666 [2018-21854]

Download as PDF Federal Register / Vol. 83, No. 195 / Tuesday, October 9, 2018 / Notices A copy of the COGME charter is available on the COGME website at: https://www.hrsa.gov/advisorycommittees/graduate-medical-edu/ index.html. A copy of the charter can also be obtained by accessing the FACA database that is maintained by the Committee Management Secretariat under the General Services Administration. The website for the FACA database is https:// www.facadatabase.gov/. Amy P. McNulty, Acting Director, Division of the Executive Secretariat. [FR Doc. 2018–21864 Filed 10–5–18; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Performance Review Board Members Title 5, U.S.C. Section 4314(c)(4) of the Civil Service Reform Act of 1978, Public Law 95–454, requires that the appointment of Performance Review Board Members be published in the Federal Register. The following persons may be named to serve on the Performance Review Boards or Panels, which oversee the evaluation of performance appraisals of Senior Executive Service members of the Department of Health and Human Services. Employee last name amozie on DSK3GDR082PROD with NOTICES1 Barry .......................... Brady ......................... Brown ........................ Coquis ....................... Fantinato ................... Fischmann ................. Gentile ....................... Goldhaber ................. Hargan ...................... Haseltine ................... Kretschmaier ............. Lewis ......................... McDaniel ................... Novy .......................... Rowell ....................... Sample ...................... Skeadas .................... Tobias ....................... Employee first name Daniel William Mark Roberto Jessica Elizabeth John Ben Eric Amy Michon Lisa Eileen Steve Scott Allen Christos Constance Dated: October 1, 2018. Charles H. McEnerney III, Director, Executive and Scientific Resources Division. [FR Doc. 2018–21855 Filed 10–5–18; 8:45 am] BILLING CODE 4151–17–P VerDate Sep<11>2014 19:13 Oct 05, 2018 Jkt 247001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the National Clinical Care Commission Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: The National Clinical Care Commission (the Commission) will conduct its inaugural meeting on October 31, 2018. The Commission will evaluate and make recommendations to the U.S. Department of Health and Human Services (HHS) Secretary and Congress regarding improvements to the coordination and leveraging of federal programs related to awareness and clinical care for complex metabolic or autoimmune diseases that result from issues related to insulin that represent a significant disease burden in the United States, which may include complications due to such diseases. DATES: The meeting will take place on October 31, 2018, from 8:00 a.m. to approximately 5:00 p.m. Eastern Time (ET). ADDRESSES: National Institutes of Health, Building 35, John Edward Porter Neuroscience Research Center [PNRC II], 35 Convent Drive, Bethesda, MD 20892. The meeting will also be held online via webcast. To register to attend the meeting, please visit the registration website at https:// events.kauffmaninc.com/events/ ncccmeetingone/. FOR FURTHER INFORMATION CONTACT: Clydette Powell, Designated Federal Official, National Clinical Care Commission, U.S. Department of Health and Human Services, Office of the Assistant Secretary for Health, Office of Disease Prevention and Health Promotion, 1101 Wootton Parkway, Suite LL–100, Rockville, MD 20852. Email: OHQ@hhs.gov. Additional information may be obtained at https:// health.gov/hcq/national-clinical-carecommission.asp. SUPPLEMENTARY INFORMATION: The National Clinical Care Commission Act (Pub. L. 115–80) requires the HHS Secretary to establish the National Clinical Care Commission. The Commission will consist of representatives of specific federal agencies and non-federal individuals and entities who represent diverse disciplines and views. The Commission will evaluate and make recommendations to the HHS Secretary SUMMARY: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 50665 and Congress regarding improvements to the coordination and leveraging of federal programs related to awareness and clinical care for complex metabolic or autoimmune diseases that result from issues related to insulin that represent a significant disease burden in the United States, which may include complications due to such diseases. This inaugural meeting of the Commission will consist of swearing-in non-federal Commission members, an overview of various federal interagency efforts surrounding diabetes programs, the establishment of the Commission subcommittee structure, and setting future agenda topics. The names and biographies of the Commission members and final meeting agenda will be available prior to the meeting at https:// health.gov/hcq/national-clinical-carecommission.asp. Public Participation at Meeting: The Commission invites public comment on issues related to the Commission’s charge either in-person at the meeting or in writing. In-person attendees who plan to provide oral comments at the Commission meeting during a designated time must submit their comments to OHQ@hhs.gov on or before October 24, 2018 and must check-in onsite. To accommodate as many individuals as possible, the time for each comment will be limited to three minutes. If more requests are received than can be accommodated, speakers will be randomly selected. The nature of the comments will not be considered in making this selection. Written comments are welcome throughout the entire development process of the Commission and may be emailed to OHQ@hhs.gov, or by mail to the following address: Public Commentary, National Clinical Care Commission, 1101 Wootton Parkway, Suite LL–100, Rockville, MD 20852. Written comments should not exceed three pages in length. To attend the Commission meeting, individuals must pre-register at the registration website at https:// events.kauffmaninc.com/events/ ncccmeetingone/. In-person and live videocast attendance options are available. In-person attendance at the meeting is limited to space available. Inperson registrations will be accepted until maximum capacity is reached and must be completed by October 25, 2018. On the day of the meeting, seating will be provided first to persons who have pre-registered. Those who have not preregistered will be accommodate on a first come, first served basis if additional seats are still available 10 minutes before the meeting start. Individuals who need special assistance, such as sign language E:\FR\FM\09OCN1.SGM 09OCN1 50666 Federal Register / Vol. 83, No. 195 / Tuesday, October 9, 2018 / Notices interpretation or other reasonable accommodations, should indicate the special accommodation when registering online or by notifying Jennifer Gillissen at jennifer.gillissen@ kauffmaninc.com by October 25. Authority: The National Clinical Care Commission is required under the National Clinical Care Commission Act (Pub. L. 115– 80). The Commission is governed by provisions of the Federal Advisory Committee Act (FACA), Public Law 92–463, as amended (5 U.S.C., App.) which sets forth standards for the formation and use of federal advisory committees. Dated: October 1, 2018. Don Wright, Deputy Assistant Secretary for Health (Disease Prevention and Health Promotion). [FR Doc. 2018–21854 Filed 10–5–18; 8:45 am] BILLING CODE 4150–32–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. The invention listed below is owned by an agency of the U.S. Government and is available for licensing 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. FOR FURTHER INFORMATION CONTACT: Peter Soukas, J.D., 301–594–8730; peter.soukas@nih.gov. Licensing information and copies of the patent applications listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852; tel. 301–496–2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications. SUPPLEMENTARY INFORMATION: Technology description follows. amozie on DSK3GDR082PROD with NOTICES1 SUMMARY: Attenuated Human Parainfluenza Virus Type 1 Expressing Ebola Virus Glycoprotein GP as an Intranasal Ebola Vaccine Description of Technology: Ebola virus (EBOV) hemorrhagic fever is one VerDate Sep<11>2014 19:13 Oct 05, 2018 Jkt 247001 of the most lethal viral infections and lacks a licensed vaccine. EBOV is transmitted by contact with body fluids from infected individuals including droplets or aerosols. Aerosolized EBOV could also be exploited for intentional virus spread. Therefore, vaccines that protect against mucosal and systemic exposure are needed. The NIH/NIAID has developed recombinant human parainfluenza virus type 1 (rHPIV1) bearing a stabilized attenuating mutation in the P/C gene to express the membrane-anchored form of EBOV glycoprotein GP as an intranasal (IN) EBOV vaccine. GP was codon optimized and expressed either as a fulllength protein or a chimeric form in which its transmembrane and cytoplasmic tail (TMCT) domains were substituted with those of the HPIV1 F protein in an effort to increase packaging into the vector particle and enhance immunogenicity. GP was inserted either preceding the N gene (pre-N) or between the N and P genes (N-P) of rHPIV1. All vectors replicated to high titers in vitro and had stable GP expression. Viruses were attenuated and replicated at low titers in the respiratory tract of African green monkeys. Two doses of candidates expressing GP from the pre-N position elicited higher GP neutralizing serum antibody titers than the N-P viruses, and unmodified GP induced higher levels than its TMCT counterpart. Unmodified EBOV GP was packaged into the HPIV1 particle, and the TMCT modification did not increase packaging or immunogenicity. Overall, the candidate expressing full-length GP from the Pre-N position was the most immunogenic. This invention relates to an attenuated and immunogenic IN vaccine candidate expected to be well tolerated in humans and is available for clinical evaluation. This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration. Potential Commercial Applications: • Viral diagnostics • Vaccine research Competitive Advantages: • Ease of manufacture • Bivalent or Multivalent live attenuated vaccines • B cell and T cell activation • Low-cost vaccines • Intranasal administration/needle-free delivery Development Stage: • In vivo data assessment (animal) PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Inventors: Shirin Munir (NIAID), Matthias Lingemann (NIAID), Ursula Buchholz (NIAID), Peter Collins (NIAID). Publications: ‘‘Attenuated Human Parainfluenza Virus Type 1 Expressing Ebola Virus Glycoprotein GP Administered Intranasally Is Immunogenic in African Green Monkeys,’’ Lingemann M, Liu X, Surman S, Liang B, Herbert R, Hackenberg AD, Buchholz UJ, Collins PL, Munir S. J Virol. 2017 Apr 28;91(10). pii: e02469–16. doi: 10.1128/ JVI.02469–16. Print 2017 May 15. PMID: 28250127. Intellectual Property: HHS Reference No. E–142–2018/0. Licensing Contact: Peter Soukas, J.D., 301–594–8730; peter.soukas@nih.gov. Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize for development of a vaccine for respiratory or other infections. For collaboration opportunities, please contact Peter Soukas, J.D., 301–594–8730; peter.soukas@nih.gov. Dated: September 25, 2018. Suzanne M. Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2018–21768 Filed 10–5–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. The invention listed below is owned by an agency of the U.S. Government and is available for licensing 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. FOR FURTHER INFORMATION CONTACT: Peter Soukas, J.D., 301–594–8730; peter.soukas@nih.gov. Licensing information and copies of the patent applications listed below may be SUMMARY: E:\FR\FM\09OCN1.SGM 09OCN1

Agencies

[Federal Register Volume 83, Number 195 (Tuesday, October 9, 2018)]
[Notices]
[Pages 50665-50666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21854]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the National Clinical Care Commission

AGENCY: Office of Disease Prevention and Health Promotion, Office of 
the Assistant Secretary for Health, Office of the Secretary, Department 
of Health and Human Services.

ACTION: Notice.

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

SUMMARY: The National Clinical Care Commission (the Commission) will 
conduct its inaugural meeting on October 31, 2018. The Commission will 
evaluate and make recommendations to the U.S. Department of Health and 
Human Services (HHS) Secretary and Congress regarding improvements to 
the coordination and leveraging of federal programs related to 
awareness and clinical care for complex metabolic or autoimmune 
diseases that result from issues related to insulin that represent a 
significant disease burden in the United States, which may include 
complications due to such diseases.

DATES: The meeting will take place on October 31, 2018, from 8:00 a.m. 
to approximately 5:00 p.m. Eastern Time (ET).

ADDRESSES: National Institutes of Health, Building 35, John Edward 
Porter Neuroscience Research Center [PNRC II], 35 Convent Drive, 
Bethesda, MD 20892. The meeting will also be held online via webcast. 
To register to attend the meeting, please visit the registration 
website at https://events.kauffmaninc.com/events/ncccmeetingone/.

FOR FURTHER INFORMATION CONTACT: Clydette Powell, Designated Federal 
Official, National Clinical Care Commission, U.S. Department of Health 
and Human Services, Office of the Assistant Secretary for Health, 
Office of Disease Prevention and Health Promotion, 1101 Wootton 
Parkway, Suite LL-100, Rockville, MD 20852. Email: [email protected]. 
Additional information may be obtained at https://health.gov/hcq/national-clinical-care-commission.asp.

SUPPLEMENTARY INFORMATION: The National Clinical Care Commission Act 
(Pub. L. 115-80) requires the HHS Secretary to establish the National 
Clinical Care Commission. The Commission will consist of 
representatives of specific federal agencies and non-federal 
individuals and entities who represent diverse disciplines and views. 
The Commission will evaluate and make recommendations to the HHS 
Secretary and Congress regarding improvements to the coordination and 
leveraging of federal programs related to awareness and clinical care 
for complex metabolic or autoimmune diseases that result from issues 
related to insulin that represent a significant disease burden in the 
United States, which may include complications due to such diseases.
    This inaugural meeting of the Commission will consist of swearing-
in non-federal Commission members, an overview of various federal 
interagency efforts surrounding diabetes programs, the establishment of 
the Commission subcommittee structure, and setting future agenda 
topics. The names and biographies of the Commission members and final 
meeting agenda will be available prior to the meeting at https://health.gov/hcq/national-clinical-care-commission.asp.
    Public Participation at Meeting: The Commission invites public 
comment on issues related to the Commission's charge either in-person 
at the meeting or in writing. In-person attendees who plan to provide 
oral comments at the Commission meeting during a designated time must 
submit their comments to [email protected] on or before October 24, 2018 and 
must check-in on-site. To accommodate as many individuals as possible, 
the time for each comment will be limited to three minutes. If more 
requests are received than can be accommodated, speakers will be 
randomly selected. The nature of the comments will not be considered in 
making this selection. Written comments are welcome throughout the 
entire development process of the Commission and may be emailed to 
[email protected], or by mail to the following address: Public Commentary, 
National Clinical Care Commission, 1101 Wootton Parkway, Suite LL-100, 
Rockville, MD 20852. Written comments should not exceed three pages in 
length.
    To attend the Commission meeting, individuals must pre-register at 
the registration website at https://events.kauffmaninc.com/events/ncccmeetingone/. In-person and live videocast attendance options are 
available. In-person attendance at the meeting is limited to space 
available. In-person registrations will be accepted until maximum 
capacity is reached and must be completed by October 25, 2018. On the 
day of the meeting, seating will be provided first to persons who have 
pre-registered. Those who have not pre-registered will be accommodate 
on a first come, first served basis if additional seats are still 
available 10 minutes before the meeting start. Individuals who need 
special assistance, such as sign language

[[Page 50666]]

interpretation or other reasonable accommodations, should indicate the 
special accommodation when registering online or by notifying Jennifer 
Gillissen at [email protected] by October 25.

    Authority: The National Clinical Care Commission is required 
under the National Clinical Care Commission Act (Pub. L. 115-80). 
The Commission is governed by provisions of the Federal Advisory 
Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C., App.) 
which sets forth standards for the formation and use of federal 
advisory committees.

     Dated: October 1, 2018.
Don Wright,
Deputy Assistant Secretary for Health (Disease Prevention and Health 
Promotion).
[FR Doc. 2018-21854 Filed 10-5-18; 8:45 am]
 BILLING CODE 4150-32-P
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