83_FR_40934 83 FR 40775 - Meeting of the National Vaccine Advisory Committee

83 FR 40775 - Meeting of the National Vaccine Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 159 (August 16, 2018)

Page Range40775-40776
FR Document2018-17618

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that a meeting is scheduled to be held for the National Vaccine Advisory Committee (NVAC). The meeting will be open to the public; public comment sessions will be held during the meeting.

Federal Register, Volume 83 Issue 159 (Thursday, August 16, 2018)
[Federal Register Volume 83, Number 159 (Thursday, August 16, 2018)]
[Notices]
[Pages 40775-40776]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17618]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the National Vaccine Advisory Committee

AGENCY: National Vaccine Program Office, Office of the Assistant 
Secretary for Health, Office of the Secretary, Department of Health and 
Human Services.

ACTION: Notice.

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SUMMARY: As stipulated by the Federal Advisory Committee Act, the 
Department of Health and Human Services is hereby giving notice that a 
meeting is scheduled to be held for the National Vaccine Advisory 
Committee (NVAC). The meeting will be open to the public; public 
comment sessions will be held during the meeting.

DATES: The meeting will be held on September 12 and 13, 2018. The 
meeting times and agenda will be posted on the NVAC website at http://www.hhs.gov/nvpo/nvac/meetings/index.html as soon as they become 
available.

ADDRESSES: U.S. Department of Health and Human Services, Hubert H. 
Humphrey Building, Room 800, 200 Independence Avenue SW, Washington, DC 
20201. The meeting can also be accessed through a live webcast on both 
days of the meeting. For more information, visit http://www.hhs.gov/nvpo/nvac/meetings/index.html.
    Pre-registration is required for members of the public who wish to 
attend the meeting and who wish to participate in a public comment 
session. Individuals who wish to attend the meeting and/or participate 
in a public comment session should register at http://www.hhs.gov/nvpo/nvac/meetings/index.html. Participants may also register by emailing 
[email protected] or by calling (202) 690-5566 and providing their name, 
organization, and email address.

FOR FURTHER INFORMATION CONTACT: Ann Aikin, Acting Designated Federal 
Officer, National Vaccine Program Office, U.S. Department of Health and 
Human Services, Room 715H, Hubert H. Humphrey Building, 200 
Independence Avenue SW, Washington, DC 20201. Phone: (202) 690-5566; 
email: [email protected].

SUPPLEMENTARY INFORMATION: Pursuant to Section 2101 of the Public 
Health Service Act (42 U.S.C. 300aa-1), the Secretary of Health and 
Human Services was mandated to establish the National Vaccine Program 
to achieve optimal prevention of human infectious diseases through 
immunization and to achieve optimal prevention against adverse 
reactions to vaccines. The NVAC was established to provide advice and 
make recommendations to the Director of the National Vaccine Program on 
matters related to the Program's responsibilities. The Assistant 
Secretary for Health serves as Director of the National Vaccine 
Program. During the September 2018 NVAC meeting, sessions will consist 
of presentations on valuing vaccines, including presentations on the 
role of vaccines in combatting antibiotic resistance; vaccine 
innovation, including presentations on financing, new technologies, and 
development of new vaccines; lessons from the field, with focus on 
Ebola and the new Shingles vaccine; and a session on HPV vaccination 
for cancer prevention. Please note that agenda items will be related to 
the charge of the Committee and are subject to change as priorities 
dictate. Information on the final meeting agenda will be posted prior 
to the meeting on the NVAC website: http://www.hhs.gov/nvpo/nvac/index.html.
    Public attendance at the meeting is limited to the available space. 
Individuals who plan to attend in person and need special assistance, 
such as sign language interpretation or other reasonable 
accommodations,

[[Page 40776]]

should notify the National Vaccine Program Office at the address/phone 
number listed above at least one week prior to the meeting. For those 
unable to attend in person, a live webcast will be available. More 
information on registration and accessing the webcast can be found at 
http://www.hhs.gov/nvpo/nvac/meetings/index.html.
    Members of the public will have the opportunity to provide comments 
at the NVAC meeting during the public comment periods designated on the 
agenda. Public comments made during the meeting will be limited to 
three minutes per person to ensure time is allotted for all those 
wishing to speak. Individuals are also welcome to submit their written 
comments. Written comments should not exceed three pages in length. 
Individuals submitting written comments should email their comments to 
the National Vaccine Program Office ([email protected]) at least five 
business days prior to the meeting.

    Dated: July 31, 2018.
Roula K. Sweis,
Chief of Management and Operations, National Vaccine Program Office.
[FR Doc. 2018-17618 Filed 8-15-18; 8:45 am]
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                                                                            Federal Register / Vol. 83, No. 159 / Thursday, August 16, 2018 / Notices                                           40775

                                                ACTION:   Notice.                                       the mission of the Committee may be                   DC 20201. The meeting can also be
                                                                                                        added to the agenda.                                  accessed through a live webcast on both
                                                SUMMARY:   As stipulated by the Federal                    The public will have an opportunity                days of the meeting. For more
                                                Advisory Committee Act, the U.S.                        to present their views to the Committee               information, visit http://www.hhs.gov/
                                                Department of Health and Human                          during public comment session                         nvpo/nvac/meetings/index.html.
                                                Services is hereby giving notice that the               scheduled for the meeting. Comments                      Pre-registration is required for
                                                Advisory Committee on Blood and                         will be limited to five minutes per                   members of the public who wish to
                                                Tissue Safety and Availability                          speaker and must be pertinent to the                  attend the meeting and who wish to
                                                (ACBTSA) will hold a meeting. The                       discussion. Pre-registration is required              participate in a public comment session.
                                                meeting will be open to the public.                     for participation in the public comment               Individuals who wish to attend the
                                                DATES: The meeting will take place on                   session. Any member of the public who                 meeting and/or participate in a public
                                                Thursday, September 13, 2018, from                      would like to participate in this session             comment session should register at
                                                8:00 a.m.–5:00 p.m. ET.                                 is required to submit their name, email,              http://www.hhs.gov/nvpo/nvac/
                                                                                                        and comment summary prior to close of                 meetings/index.html. Participants may
                                                ADDRESSES: Crystal City Marriott at
                                                                                                        business on September 7, 2018. If it is               also register by emailing nvpo@hhs.gov
                                                Reagan National Airport, 1999 Jefferson                                                                       or by calling (202) 690–5566 and
                                                                                                        not possible to provide 30 copies of the
                                                Davis Highway, Arlington, VA 22202.                                                                           providing their name, organization, and
                                                                                                        material to be distributed at the meeting,
                                                FOR FURTHER INFORMATION CONTACT: Mr.                    then individuals are requested to                     email address.
                                                James Berger, Designated Federal Officer                provide a minimum of one (1) copy of                  FOR FURTHER INFORMATION CONTACT: Ann
                                                for the ACBTSA, Senior Advisor for                      the document(s) to be distributed prior               Aikin, Acting Designated Federal
                                                Blood and Tissue Policy, Office of the                  to the close of business on September 7,              Officer, National Vaccine Program
                                                Assistant Secretary for Health,                         2018. It is also requested that any                   Office, U.S. Department of Health and
                                                Department of Health and Human                          member of the public who wishes to                    Human Services, Room 715H, Hubert H.
                                                Services, Mary E. Switzer Building, 330                 provide comments to the Committee                     Humphrey Building, 200 Independence
                                                C Street SW, Suite L100, Washington,                    utilizing electronic data projection                  Avenue SW, Washington, DC 20201.
                                                DC 20024. Phone: (202) 795–7697; Fax:                   submit the necessary material to the                  Phone: (202) 690–5566; email: nvac@
                                                (202) 691–2102; Email: ACBTSA@                          Designated Federal Officer prior to the               hhs.gov.
                                                hhs.gov.                                                close of business on September 7, 2018.               SUPPLEMENTARY INFORMATION: Pursuant
                                                SUPPLEMENTARY INFORMATION:       The                      Dated: August 9, 2018.                              to Section 2101 of the Public Health
                                                ACBTSA provides advice to the                           James J. Berger,                                      Service Act (42 U.S.C. 300aa–1), the
                                                Secretary through the Assistant                         Senior Advisor for Blood and Tissue Policy.           Secretary of Health and Human Services
                                                Secretary for Health. The Committee                     [FR Doc. 2018–17617 Filed 8–15–18; 8:45 am]           was mandated to establish the National
                                                advises on a range of policy issues to                                                                        Vaccine Program to achieve optimal
                                                                                                        BILLING CODE 4150–41–P
                                                include: (1) Identification of public                                                                         prevention of human infectious diseases
                                                health issues through surveillance of                                                                         through immunization and to achieve
                                                blood and tissue safety issues with                     DEPARTMENT OF HEALTH AND                              optimal prevention against adverse
                                                national biovigilance data tools; (2)                   HUMAN SERVICES                                        reactions to vaccines. The NVAC was
                                                identification of public health issues                                                                        established to provide advice and make
                                                that affect availability of blood, blood                Meeting of the National Vaccine                       recommendations to the Director of the
                                                products, and tissues; (3) broad public                 Advisory Committee                                    National Vaccine Program on matters
                                                health, ethical, and legal issues related                                                                     related to the Program’s responsibilities.
                                                to the safety of blood, blood products,                 AGENCY:  National Vaccine Program                     The Assistant Secretary for Health
                                                and tissues; (4) the impact of various                  Office, Office of the Assistant Secretary             serves as Director of the National
                                                economic factors (e.g., product cost and                for Health, Office of the Secretary,                  Vaccine Program. During the September
                                                supply) on safety and availability of                   Department of Health and Human                        2018 NVAC meeting, sessions will
                                                blood, blood products, and tissues; (5)                 Services.                                             consist of presentations on valuing
                                                risk communications related to blood                    ACTION: Notice.                                       vaccines, including presentations on the
                                                transfusion and tissue transplantation;                                                                       role of vaccines in combatting antibiotic
                                                                                                        SUMMARY:   As stipulated by the Federal
                                                and (6) identification of infectious                                                                          resistance; vaccine innovation,
                                                                                                        Advisory Committee Act, the
                                                disease transmission issues for blood,                                                                        including presentations on financing,
                                                                                                        Department of Health and Human
                                                organs, blood stem cells and tissues.                                                                         new technologies, and development of
                                                                                                        Services is hereby giving notice that a
                                                The Committee has met regularly since                                                                         new vaccines; lessons from the field,
                                                                                                        meeting is scheduled to be held for the
                                                its establishment in 1997. The                                                                                with focus on Ebola and the new
                                                                                                        National Vaccine Advisory Committee
                                                Committee will meet on September 13,                                                                          Shingles vaccine; and a session on HPV
                                                                                                        (NVAC). The meeting will be open to
                                                2018 to receive presentations on                                                                              vaccination for cancer prevention.
                                                                                                        the public; public comment sessions
                                                material pertinent to exploring the topic                                                                     Please note that agenda items will be
                                                                                                        will be held during the meeting.
                                                of ‘‘Defining a tolerable risk for                                                                            related to the charge of the Committee
                                                infectious diseases from a patient’s                    DATES: The meeting will be held on
                                                                                                                                                              and are subject to change as priorities
                                                perspective.’’ Historical aspects of                    September 12 and 13, 2018. The                        dictate. Information on the final meeting
                                                combating infectious disease risks in the               meeting times and agenda will be                      agenda will be posted prior to the
                                                blood supply, ongoing national and                      posted on the NVAC website at http://
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                                                                                                                                                              meeting on the NVAC website: http://
                                                global efforts towards mitigating those                 www.hhs.gov/nvpo/nvac/meetings/                       www.hhs.gov/nvpo/nvac/index.html.
                                                risks, and emerging considerations shall                index.html as soon as they become                        Public attendance at the meeting is
                                                be presented to the Committee. The full                 available.                                            limited to the available space.
                                                Committee will receive an interim                       ADDRESSES:U.S. Department of Health                   Individuals who plan to attend in
                                                report from the ACBTSA Blood                            and Human Services, Hubert H.                         person and need special assistance,
                                                Sustainability subcommittee and                         Humphrey Building, Room 800, 200                      such as sign language interpretation or
                                                additional topics that are pertinent to                 Independence Avenue SW, Washington,                   other reasonable accommodations,


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                                                40776                       Federal Register / Vol. 83, No. 159 / Thursday, August 16, 2018 / Notices

                                                should notify the National Vaccine                        Contact Person: Zhuqing (Charlie) Li,                 Contact Person: Alicia J. Dombroski, Ph.D.,
                                                Program Office at the address/phone                     Ph.D., Scientific Review Officer, Scientific          Director, Division of Extramural Activities,
                                                number listed above at least one week                   Review Program, Division of Extramural                National Institute of Dental & Craniofacial
                                                                                                        Activities, Room #3G41B, National Institutes          Research, National Institutes of Health,
                                                prior to the meeting. For those unable to
                                                                                                        of Health/NIAID, 5601 Fishers Lane,                   Bethesda, MD 20892, 301–594–4805,
                                                attend in person, a live webcast will be                MSC9823, Bethesda, MD 20892–9823, (240)               adombroski@nidcr.nih.gov.
                                                available. More information on                          669–5068, zhuqing.li@nih.gov.                           In the interest of security, NIH has
                                                registration and accessing the webcast                                                                        instituted stringent procedures for entrance
                                                                                                        (Catalogue of Federal Domestic Assistance
                                                can be found at http://www.hhs.gov/                     Program Nos. 93.855, Allergy, Immunology,             onto the NIH campus. All visitor vehicles,
                                                nvpo/nvac/meetings/index.html.                          and Transplantation Research; 93.856,                 including taxicabs, hotel, and airport shuttles
                                                   Members of the public will have the                  Microbiology and Infectious Diseases                  will be inspected before being allowed on
                                                opportunity to provide comments at the                  Research, National Institutes of Health, HHS)         campus. Visitors will be asked to show one
                                                NVAC meeting during the public                                                                                form of identification (for example, a
                                                                                                          Dated: August 10, 2018.                             government-issued photo ID, driver’s license,
                                                comment periods designated on the
                                                agenda. Public comments made during                     Natasha M. Copeland,                                  or passport) and to state the purpose of their
                                                the meeting will be limited to three                    Program Analyst, Office of Federal Advisory           visit.
                                                                                                        Committee Policy.                                       Information is also available on the
                                                minutes per person to ensure time is                                                                          Institute’s/Center’s home page: http://
                                                allotted for all those wishing to speak.                [FR Doc. 2018–17676 Filed 8–15–18; 8:45 am]
                                                                                                                                                              www.nidcr.nih.gov/about, where an agenda
                                                Individuals are also welcome to submit                  BILLING CODE 4140–01–P
                                                                                                                                                              and any additional information for the
                                                their written comments. Written                                                                               meeting will be posted when available.
                                                comments should not exceed three                                                                              (Catalogue of Federal Domestic Assistance
                                                pages in length. Individuals submitting                 DEPARTMENT OF HEALTH AND
                                                                                                                                                              Program Nos. 93.121, Oral Diseases and
                                                written comments should email their                     HUMAN SERVICES                                        Disorders Research, National Institutes of
                                                comments to the National Vaccine                        National Institutes of Health
                                                                                                                                                              Health, HHS)
                                                Program Office (nvpo@hhs.gov) at least                                                                          Dated: August 10, 2018.
                                                five business days prior to the meeting.                National Institute of Dental and                      Natasha M. Copeland,
                                                  Dated: July 31, 2018.                                 Craniofacial Research; Notice of                      Program Analyst, Office of Federal Advisory
                                                Roula K. Sweis,                                         Meeting                                               Committee Policy.
                                                Chief of Management and Operations,                                                                           [FR Doc. 2018–17679 Filed 8–15–18; 8:45 am]
                                                National Vaccine Program Office.                           Pursuant to section 10(d) of the
                                                                                                                                                              BILLING CODE 4140–01–P
                                                [FR Doc. 2018–17618 Filed 8–15–18; 8:45 am]
                                                                                                        Federal Advisory Committee Act, as
                                                                                                        amended, notice is hereby given of a
                                                BILLING CODE 4150–44–P
                                                                                                        meeting of the National Advisory Dental               DEPARTMENT OF HEALTH AND
                                                                                                        and Craniofacial Research Council.                    HUMAN SERVICES
                                                DEPARTMENT OF HEALTH AND                                   The meeting will be open to the
                                                HUMAN SERVICES                                          public as indicated below, with                       National Institutes of Health
                                                                                                        attendance limited to space available.
                                                National Institutes of Health                           Individuals who plan to attend and                    National Institute on Drug Abuse;
                                                                                                        need special assistance, such as sign                 Notice of Closed Meeting
                                                National Institute of Allergy and                       language interpretation or other
                                                Infectious Diseases; Notice of Closed                                                                           Pursuant to section 10(d) of the
                                                                                                        reasonable accommodations, should                     Federal Advisory Committee Act, as
                                                Meeting                                                 notify the Contact Person listed below                amended, notice is hereby given of the
                                                  Pursuant to section 10(d) of the                      in advance of the meeting.                            following meeting.
                                                Federal Advisory Committee Act, as                         The meeting will be closed to the                    The meeting will be closed to the
                                                amended, notice is hereby given of the                  public in accordance with the                         public in accordance with the
                                                following meeting.                                      provisions set forth in sections                      provisions set forth in sections
                                                  The meeting will be closed to the                     552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,            552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                public in accordance with the                           as amended. The grant applications and                as amended. The contract proposals and
                                                provisions set forth in sections                        the discussions could disclose                        the discussions could disclose
                                                552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,              confidential trade secrets or commercial              confidential trade secrets or commercial
                                                as amended. The grant applications and                  property such as patentable material,                 property such as patentable material,
                                                the discussions could disclose                          and personal information concerning                   and personal information concerning
                                                confidential trade secrets or commercial                individuals associated with the grant                 individuals associated with the contract
                                                property such as patentable material,                   applications, the disclosure of which                 proposals, the disclosure of which
                                                and personal information concerning                     would constitute a clearly unwarranted                would constitute a clearly unwarranted
                                                individuals associated with the grant                   invasion of personal privacy.                         invasion of personal privacy.
                                                applications, the disclosure of which                     Name of Committee: National Advisory                  Name of Committee: National Institute on
                                                would constitute a clearly unwarranted                  Dental and Craniofacial Research Council.             Drug Abuse Special Emphasis Panel;
                                                invasion of personal privacy.                             Date: September 13, 2018.                           Analytical Services Center for Medications
                                                  Name of Committee: National Institute of                Open: 8:30 a.m. to 12:30 p.m.                       Development (8938).
                                                Allergy and Infectious Diseases Special                   Agenda: Report to the Director, NIDCR.                Date: September 25, 2018.
                                                                                                          Place: National Institutes of Health                  Time: 10:00 a.m. to 12:00 p.m.
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                                                Emphasis Panel; NIAID Clinical Trial
                                                Planning Grant (R34).                                   Building 35, Room 620/630, 35 Convent                   Agenda: To review and evaluate contract
                                                  Date: September 10, 2018.                             Drive, Bethesda, MD 20892.                            proposals.
                                                  Time: 1:00 p.m. to 3:00 p.m.                            Closed: 1:30 p.m. to 3:00 p.m.                        Place: National Institutes of Health,
                                                  Agenda: To review and evaluate grant                    Agenda: To review and evaluate grant                Neuroscience Center, 6001 Executive
                                                applications.                                           applications and/or proposals.                        Boulevard, Rockville, MD 20852 (Telephone
                                                  Place: National Institutes of Health, 5601              Place: National Institutes of Health,               Conference Call).
                                                Fishers Lane, Rockville, MD 20892                       Building 35, Room 620/630, 35 Convent                   Contact Person: Lyle Furr, Scientific
                                                (Telephone Conference Call).                            Drive, Bethesda, MD 20892.                            Review Officer, Office of Extramural Affairs,



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Document Created: 2018-08-16 01:01:58
Document Modified: 2018-08-16 01:01:58
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
ActionNotice.
DatesThe meeting will be held on September 12 and 13, 2018. The meeting times and agenda will be posted on the NVAC website at http:// www.hhs.gov/nvpo/nvac/meetings/index.html as soon as they become available.
ContactAnn Aikin, Acting Designated Federal Officer, National Vaccine Program Office, U.S. Department of Health and Human Services, Room 715H, Hubert H. Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201. Phone: (202) 690-5566; email: [email protected]
FR Citation83 FR 40775 

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