82_FR_18222 82 FR 18150 - Meeting of the National Vaccine Advisory Committee

82 FR 18150 - Meeting of the National Vaccine Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 82, Issue 72 (April 17, 2017)

Page Range18150-18151
FR Document2017-07707

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 82 Issue 72 (Monday, April 17, 2017)
[Federal Register Volume 82, Number 72 (Monday, April 17, 2017)]
[Notices]
[Pages 18150-18151]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-07707]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the National Vaccine Advisory Committee

AGENCY: Office of the Secretary, Office of the Assistant Secretary for 
Health, National Vaccine Program Office, 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 June 6 and 7, 2017. The meeting 
times and agenda will be posted on the NVAC Web site 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, Great Hall, 200 Independence Avenue SW., Washington, 
DC 20201.
    Pre-registration is required for members of the public who wish to 
attend the meeting and who wish to participate in the public comment 
session. Individuals who wish to attend the meeting and/or participate 
in the public comment session should register at http://www.hhs.gov/nvpo/nvac/meetings/index.html. Participants may also register by 
emailing nvpo@hhs.gov or by calling (202) 690-5566 and providing their 
name, organization and email address.
    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.

FOR FURTHER INFORMATION CONTACT: 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: nvpo@hhs.gov.

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

[[Page 18151]]

serves as Director of the National Vaccine Program.
    During the June 2017 NVAC meeting, sessions will include an update 
on the Secretary of the Department of Health and Human Services' report 
on vaccine innovation to Congress in response to the 21st Century Cures 
Act; presentations on immunization information systems and inter-
jurisdictional data exchange; and an update on vaccine confidence-
related projects. 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 Web site: 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, 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 (nvpo@hhs.gov) at least five 
business days prior to the meeting.

    Dated: March 23, 2017.
Jewel Mullen,
Acting Director, National Vaccine Program Office.
[FR Doc. 2017-07707 Filed 4-14-17; 8:45 am]
 BILLING CODE 4150-44-P



                                                  18150                                     Federal Register / Vol. 82, No. 72 / Monday, April 17, 2017 / Notices

                                                  advisory committee meeting. The                                           invited to make a short presentation
                                                  nominators of these substances will be                                    supporting the nomination.

                                                                                            Drug                                                                                    Use(s) reviewed

                                                  Nicotinamide adenine dinucleotide ..........................................                    Reducing fatigue in multiple sclerosis.
                                                  Nicotinamide adenine dinucleotide disodium reduced .............                                Reduce symptoms of fatigue in chronic fatigue syndrome.
                                                  Nettle (Urtica dioica) whole plant .............................................                Glycemic control.
                                                  Ubiquinol ...................................................................................   Glycemic control.
                                                  Vanadyl sulfate .........................................................................       Diabetes, hypoglycemia, hyperlipidemia, heart disease, preventing cancer.
                                                  Artemisinin ................................................................................    Malaria, protozoal infections (particularly toxoplasmosis), helminthic infections,
                                                                                                                                                    stomach ulcers, cancer.



                                                     The committee also intends to discuss                                  speakers for the scheduled open public                    the public; public comment sessions
                                                  oral solid modified release drug                                          hearing session. The contact person will                  will be held during the meeting.
                                                  products that employ coated systems,                                      notify interested persons regarding their                 DATES: The meeting will be held on June
                                                  which were nominated for the Difficult                                    request to speak by April 17, 2017.                       6 and 7, 2017. The meeting times and
                                                  to Compound List. The nominators will                                        Persons attending FDA’s advisory                       agenda will be posted on the NVAC
                                                  be invited to make a short presentation                                   committee meetings are advised that the                   Web site at http://www.hhs.gov/nvpo/
                                                  supporting the nomination.                                                Agency is not responsible for providing                   nvac/meetings/index.html as soon as
                                                     FDA intends to make background                                         access to electrical outlets.                             they become available.
                                                  material available to the public no later                                    FDA welcomes the attendance of the                     ADDRESSES: U.S. Department of Health
                                                  than 2 business days before the meeting.                                  public at its advisory committee                          and Human Services, Hubert H.
                                                  If FDA is unable to post the background                                   meetings and will make every effort to                    Humphrey Building, Great Hall, 200
                                                  material on its Web site prior to the                                     accommodate persons with disabilities.                    Independence Avenue SW.,
                                                  meeting, the background material will                                     If you require accommodations due to a                    Washington, DC 20201.
                                                  be made publicly available at the                                         disability, please contact Cindy Hong at                     Pre-registration is required for
                                                  location of the advisory committee                                        least 7 days in advance of the meeting.                   members of the public who wish to
                                                  meeting, and the background material                                         FDA is committed to the orderly                        attend the meeting and who wish to
                                                  will be posted on FDA’s Web site after                                    conduct of its advisory committee                         participate in the public comment
                                                  the meeting. Background material is                                       meetings. Please visit our Web site at                    session. Individuals who wish to attend
                                                  available at http://www.fda.gov/                                          http://www.fda.gov/                                       the meeting and/or participate in the
                                                  AdvisoryCommittees/Calendar/                                              AdvisoryCommittees/                                       public comment session should register
                                                  default.htm. Scroll down to the                                           AboutAdvisoryCommittees/                                  at http://www.hhs.gov/nvpo/nvac/
                                                  appropriate advisory committee meeting                                    ucm111462.htm for procedures on                           meetings/index.html. Participants may
                                                  link.                                                                     public conduct during advisory                            also register by emailing nvpo@hhs.gov
                                                     Procedure: Interested persons may                                      committee meetings.                                       or by calling (202) 690–5566 and
                                                  present data, information, or views,                                         Notice of this meeting is given under                  providing their name, organization and
                                                  orally or in writing, on issues pending                                   the Federal Advisory Committee Act (5                     email address.
                                                  before the committee. All electronic and                                  U.S.C. app. 2).                                              The meeting can also be accessed
                                                  written submissions submitted to the                                                                                                through a live webcast on both days of
                                                                                                                              Dated: April 11, 2017.
                                                  Docket (see the ADDRESSES section) on                                                                                               the meeting. For more information, visit
                                                  or before April 24, 2017, will be                                         Anna K. Abram,
                                                                                                                            Deputy Commissioner for Policy, Planning,                 http://www.hhs.gov/nvpo/nvac/
                                                  provided to the committee. Oral                                                                                                     meetings/index.html.
                                                  presentations from the public will be                                     Legislation, and Analysis.
                                                                                                                            [FR Doc. 2017–07667 Filed 4–14–17; 8:45 am]               FOR FURTHER INFORMATION CONTACT:
                                                  scheduled between approximately 10:15
                                                  a.m. and 10:25 a.m., 11:35 a.m. and                                       BILLING CODE 4164–01–P                                    National Vaccine Program Office, U.S.
                                                  11:45 a.m., 1:45 p.m. and 1:55 p.m., 2:50                                                                                           Department of Health and Human
                                                  p.m. and 3 p.m., and 4:10 p.m. and 4:20                                                                                             Services, Room 715H, Hubert H.
                                                  p.m. on May 8, 2017, and between                                          DEPARTMENT OF HEALTH AND                                  Humphrey Building, 200 Independence
                                                  approximately 10 a.m. and 10:10 a.m.                                      HUMAN SERVICES                                            Avenue SW., Washington, DC 20201.
                                                  and 11:35 a.m. and 11:50 a.m. on May                                                                                                Phone: (202) 690–5566; email: nvpo@
                                                                                                                            Meeting of the National Vaccine                           hhs.gov.
                                                  9, 2017. Those individuals interested in                                  Advisory Committee
                                                  making formal oral presentations should                                                                                             SUPPLEMENTARY INFORMATION:    Pursuant
                                                  notify the contact person and submit a                                    AGENCY:  Office of the Secretary, Office                  to Section 2101 of the Public Health
                                                  brief statement of the general nature of                                  of the Assistant Secretary for Health,                    Service Act (42 U.S.C. 300aa–1), the
                                                  the evidence or arguments they wish to                                    National Vaccine Program Office,                          Secretary of Health and Human Services
                                                  present, the names and addresses of                                       Department of Health and Human                            was mandated to establish the National
                                                  proposed participants, and an                                             Services.                                                 Vaccine Program to achieve optimal
                                                  indication of the approximate time                                        ACTION: Notice.                                           prevention of human infectious diseases
                                                  requested to make their presentation on                                                                                             through immunization and to achieve
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                                                  or before April 14, 2017. Time allotted                                   SUMMARY:   As stipulated by the Federal                   optimal prevention against adverse
                                                  for each presentation may be limited. If                                  Advisory Committee Act, the                               reactions to vaccines. The NVAC was
                                                  the number of registrants requesting to                                   Department of Health and Human                            established to provide advice and make
                                                  speak is greater than can be reasonably                                   Services is hereby giving notice that a                   recommendations to the Director of the
                                                  accommodated during the scheduled                                         meeting is scheduled to be held for the                   National Vaccine Program on matters
                                                  open public hearing session, FDA may                                      National Vaccine Advisory Committee                       related to the Program’s responsibilities.
                                                  conduct a lottery to determine the                                        (NVAC). The meeting will be open to                       The Assistant Secretary for Health


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                                                                                 Federal Register / Vol. 82, No. 72 / Monday, April 17, 2017 / Notices                                            18151

                                                  serves as Director of the National                      Office of the Assistant Secretary for                 September 18, 2014, authority was given
                                                  Vaccine Program.                                        Health.                                               to the Secretary of HHS to establish the
                                                     During the June 2017 NVAC meeting,                   ACTION: Notice.                                       Advisory Council, in consultation with
                                                  sessions will include an update on the                                                                        the Secretaries of Defense and
                                                  Secretary of the Department of Health                   SUMMARY:    As stipulated by the Federal              Agriculture. Activities of the Advisory
                                                  and Human Services’ report on vaccine                   Advisory Committee Act, the                           Council are governed by the provisions
                                                  innovation to Congress in response to                   Department of Health and Human                        of Public Law 92–463, as amended (5
                                                  the 21st Century Cures Act;                             Services (HHS) is hereby giving notice                U.S.C. App.), which sets forth standards
                                                  presentations on immunization                           that a meeting is scheduled to be held                for the formation and use of federal
                                                  information systems and inter-                          for the Presidential Advisory Council on              advisory committees.
                                                  jurisdictional data exchange; and an                    Combating Antibiotic-Resistant Bacteria                  The Advisory Council will provide
                                                  update on vaccine confidence-related                    (Advisory Council). The meeting will be               advice, information, and
                                                  projects. Please note that agenda items                 open to the public; a public comment                  recommendations to the Secretary of
                                                  will be related to the charge of the                    session will be held during the meeting.              HHS regarding programs and policies
                                                                                                          Pre-registration is required for members              intended to support and evaluate the
                                                  Committee and are subject to change as
                                                                                                          of the public who wish to attend the                  implementation of Executive Order
                                                  priorities dictate. Information on the
                                                                                                          meeting and who wish to participate in                13676, including the National Strategy
                                                  final meeting agenda will be posted
                                                                                                          the public comment session. Individuals               for Combating Antibiotic-Resistant
                                                  prior to the meeting on the NVAC Web
                                                                                                          who wish to attend the meeting and/or                 Bacteria and the National Action Plan
                                                  site: http://www.hhs.gov/nvpo/nvac/
                                                                                                          send in their public comment via email                for Combating Antibiotic-Resistant
                                                  index.html.
                                                                                                          should send an email to CARB@hhs.gov.                 Bacteria. The Advisory Council shall
                                                     Public attendance at the meeting is                  Registration information is available on              function solely for advisory purposes.
                                                  limited to the available space.                         the Web site http://www.hhs.gov/ash/                     In carrying out its mission, the
                                                  Individuals who plan to attend in                       carb/ and must be completed by April                  Advisory Council will provide advice,
                                                  person and need special assistance,                     25, 2017; all in-person attendees must                information, and recommendations to
                                                  such as sign language interpretation or                 pre-register by this date. Additional                 the Secretary regarding programs and
                                                  other reasonable accommodations,                        information about registering for the                 policies intended to preserve the
                                                  should notify the National Vaccine                      meeting and providing public comment                  effectiveness of antibiotics by
                                                  Program Office at the address/phone                     can be obtained at http://www.hhs.gov/                optimizing their use; advance research
                                                  number listed above at least one week                   ash/carb/ on the Meetings page.                       to develop improved methods for
                                                  prior to the meeting. For those unable to                                                                     combating antibiotic resistance and
                                                                                                          DATES: The meeting is scheduled to be
                                                  attend in person, a live webcast will be                                                                      conducting antibiotic stewardship;
                                                                                                          held on May 3, 2017, from 9:00 a.m. to
                                                  available. More information on                                                                                strengthen surveillance of antibiotic-
                                                                                                          5:00 p.m. ET, and May 4, 2017, from
                                                  registration and accessing the webcast                                                                        resistant bacterial infections; prevent
                                                                                                          9:00 a.m. to 3:00 p.m. ET (times are
                                                  can be found at http://www.hhs.gov/                                                                           the transmission of antibiotic-resistant
                                                                                                          tentative and subject to change). The
                                                  nvpo/nvac/meetings/index.html.                                                                                bacterial infections; advance the
                                                                                                          confirmed times and agenda items for
                                                     Members of the public will have the                  the meeting will be posted on the Web                 development of rapid point-of-care and
                                                  opportunity to provide comments at the                  site for the Advisory Council at http://              agricultural diagnostics; further research
                                                  NVAC meeting during the public                          www.hhs.gov/ash/carb/ when this                       on new treatments for bacterial
                                                  comment periods designated on the                       information becomes available. Pre-                   infections; develop alternatives to
                                                  agenda. Public comments made during                     registration for attending the meeting in             antibiotics for agricultural purposes;
                                                  the meeting will be limited to three                    person is required to be completed no                 maximize the dissemination of up-to-
                                                  minutes per person to ensure time is                    later than April 25, 2017; public                     date information on the appropriate and
                                                  allotted for all those wishing to speak.                attendance at the meeting is limited to               proper use of antibiotics to the general
                                                  Individuals are also welcome to submit                  the available space.                                  public and human and animal
                                                  their written comments. Written                                                                               healthcare providers; and improve
                                                                                                          ADDRESSES: U.S. Department of Health
                                                  comments should not exceed three                                                                              international coordination of efforts to
                                                  pages in length. Individuals submitting                 and Human Services, Hubert H.
                                                                                                                                                                combat antibiotic resistance.
                                                  written comments should email their                     Humphrey Building, Great Hall, 200
                                                                                                                                                                   The first day of the public meeting,
                                                  comments to the National Vaccine                        Independence Avenue SW.,
                                                                                                                                                                May 3, 2017, will be dedicated to the
                                                  Program Office (nvpo@hhs.gov) at least                  Washington, DC 20201.                                 topic of Infection Prevention and
                                                                                                             The meeting can also be accessed
                                                  five business days prior to the meeting.                                                                      Control for Animal Health. The three
                                                                                                          through a live webcast on the day of the
                                                    Dated: March 23, 2017.                                                                                      working groups on Incentives for
                                                                                                          meeting. For more information, visit
                                                  Jewel Mullen,
                                                                                                                                                                Diagnostics, Therapeutics/Anti-
                                                                                                          http://www.hhs.gov/ash/carb/.
                                                                                                                                                                Infectives, and Vaccines, will report
                                                  Acting Director, National Vaccine Program               FOR FURTHER INFORMATION CONTACT:
                                                  Office.
                                                                                                                                                                their preliminary findings to the full
                                                                                                          Jomana Musmar, Acting Designated                      Advisory Council for deliberation on the
                                                  [FR Doc. 2017–07707 Filed 4–14–17; 8:45 am]             Federal Officer, Presidential Advisory                second day of the public meeting, May
                                                  BILLING CODE 4150–44–P                                  Council on Combating Antibiotic-                      4, 2017; no vote will be held. The
                                                                                                          Resistant Bacteria, Office of the                     meeting agenda will be posted on the
                                                                                                          Assistant Secretary for Health, U.S.                  Advisory Council Web site at http://
                                                  DEPARTMENT OF HEALTH AND                                Department of Health and Human                        www.hhs.gov/ash/carb/ when it has
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                                                  HUMAN SERVICES                                          Services, Room 715H, Hubert H.                        been finalized. All agenda items are
                                                                                                          Humphrey Building, 200 Independence                   tentative and subject to change.
                                                  Meeting of the Presidential Advisory                    Avenue SW., Washington, DC 20201.
                                                  Council on Combating Antibiotic-                                                                                 Public attendance at the meeting is
                                                                                                          Phone: (202) 690–5566; email: CARB@                   limited to the available space.
                                                  Resistant Bacteria                                      hhs.gov.                                              Individuals who plan to attend and
                                                  AGENCY:Department of Health and                         SUPPLEMENTARY INFORMATION: Under                      need special assistance, such as sign
                                                  Human Services, Office of the Secretary,                Executive Order 13676, dated                          language interpretation or other


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Document Created: 2018-08-25 11:28:02
Document Modified: 2018-08-25 11:28:02
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 June 6 and 7, 2017. The meeting times and agenda will be posted on the NVAC Web site at http:// www.hhs.gov/nvpo/nvac/meetings/index.html as soon as they become available.
ContactNational 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 Citation82 FR 18150 

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