83_FR_14528 83 FR 14463 - Solicitation of Nominations for Membership on the National Vaccine Advisory Committee

83 FR 14463 - Solicitation of Nominations for Membership on the National Vaccine Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 65 (April 4, 2018)

Page Range14463-14464
FR Document2018-06890

The National Vaccine Program Office (NVPO), a program office within the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is soliciting nominations of qualified candidates to be considered for appointment as public members to the National Vaccine Advisory Committee (NVAC). The activities of this Committee are governed by the Federal Advisory Committee Act (FACA). Management and support of the NVAC and its activities are the responsibility of the NVPO. The NVAC serves an advisory role, providing recommendations to the Assistant Secretary for Health in his/her capacity as the Director of the National Vaccine Program, on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States; recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assistant Secretary for Health in the implementation of Sections 2102 and 2103 of the PHS Act; and identifies annually the most important areas of government and non-government cooperation that should be considered in implementing Sections 2102 and 2103 of the PHS Act.

Federal Register, Volume 83 Issue 65 (Wednesday, April 4, 2018)
[Federal Register Volume 83, Number 65 (Wednesday, April 4, 2018)]
[Notices]
[Pages 14463-14464]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06890]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Solicitation of Nominations for Membership on 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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    Authority: 42 U.S.C. 300aa-5, Section 2105 of the Public Health 
Service (PHS) Act, as amended. The National Vaccine Advisory 
Committee is governed by the provisions of Public Law 92-463, as 
amended (5 U.S.C. Appendix 2), which sets forth standards for the 
formation and use of advisory committees.

SUMMARY: The National Vaccine Program Office (NVPO), a program office 
within the Office of the Assistant Secretary for Health, Department of 
Health and Human Services (HHS), is soliciting nominations of qualified 
candidates to be considered for appointment as public members to the 
National Vaccine Advisory Committee (NVAC). The activities of this 
Committee are governed by the Federal Advisory Committee Act (FACA). 
Management and support of the NVAC and its activities are the 
responsibility of the NVPO.
    The NVAC serves an advisory role, providing recommendations to the 
Assistant Secretary for Health in his/her capacity as the Director of 
the National Vaccine Program, on matters related to the Program's 
responsibilities. Specifically, the Committee studies and recommends 
ways to encourage the availability of an adequate supply of safe and 
effective vaccination products in the United States; recommends 
research priorities and other measures to enhance the safety and 
efficacy of vaccines. The Committee also advises the Assistant 
Secretary for Health in the implementation of Sections 2102 and 2103 of 
the PHS Act; and identifies annually the most important areas of 
government and non-government cooperation that should be considered in 
implementing Sections 2102 and 2103 of the PHS Act.

DATES: All nominations for membership on the Committee must be received 
no later than 5:00 p.m. EDT on May 4, 2018, to the address listed 
below.

ADDRESSES: Nominations should be emailed to [email protected].

FOR FURTHER INFORMATION CONTACT: National Vaccine Program Office, 
Department of Health and Human Services, 200 Independence Avenue SW, 
Room 715-H, Washington, DC 20201; (202) 690-5566; [email protected].
    A copy of the committee charter which includes the NVAC's structure 
and functions as well as a list of the current membership can be 
obtained by accessing the NVAC website at: http://www.hhs.gov/nvpo/nvac/index.html.

SUPPLEMENTARY INFORMATION: 
    Committee Function, Qualifications, and Information Required: As 
part of an ongoing effort to enhance deliberations and discussions with 
the public on vaccine and immunization policy, nominations are being 
sought for interested individuals to serve on the NVAC. Committee 
members provide peer review, consultation, advice, and recommendations 
to the Assistant Secretary for Health, in his/her capacity as the 
Director of the National Vaccine Program, on matters related to the 
Program's responsibilities. Individuals selected for appointment to the 
NVAC will serve as voting members. The NVAC consists of 17 voting 
members: 15 public members, including the Chair, and two representative 
members. Individuals selected for appointment to the NVAC can be 
invited to serve terms of up to four years. Selection of members is 
based on candidates'

[[Page 14464]]

qualifications to contribute to the accomplishment of NVAC's 
objectives. Interested candidates should demonstrate a willingness to 
commit time to NVAC activities and the ability to work constructively 
and effectively on committees.
    Public Members: Public members are individuals who are appointed to 
the NVAC to exercise their own independent best judgment on behalf of 
the government. It is expected that public members will discuss and 
deliberate in a manner that is free from conflicts of interest. Public 
members to the NVAC shall be selected from individuals who are engaged 
in vaccine research or the manufacture of vaccines, or who are 
physicians, members of parent organizations concerned with 
immunizations, representatives of state or local health agencies, or 
public health organizations.
    Representative Members: Representative members are individuals who 
are appointed to the NVAC to provide the views of industry or a special 
interest group. While they may be experts in various topic areas 
discussed by the Committee, they should not present their own 
viewpoints, but rather those of the industry or special interest group 
they represent. NVAC representative members shall serve specifically to 
represent the viewpoints or perspectives of the vaccine manufacturing 
industry or groups engaged in vaccine research or the manufacture of 
vaccines.
    This announcement is to solicit nominations of qualified candidates 
to fill positions in the public and representative member category of 
the NVAC, including positions that are scheduled to be vacated during 
the 2019 calendar year. Applications received in response and not 
appointed may also be considered for future vacancies that occur.
    Travel reimbursement and compensation for services provided to the 
committee: All NVAC members are authorized to receive the prescribed 
per diem allowance and reimbursement for travel expenses that are 
incurred to attend meetings and conduct authorized NVAC-related 
business, in accordance with standard government travel regulations. 
Members appointed to the NVAC as public members (see definition above) 
also are authorized to receive a stipend for services provided at 
public meetings of the Committee. All other services that are performed 
by the public members outside the Committee meetings shall be provided 
without compensation. Representative members (see definition above) 
will serve without compensation.
    Expertise sought for the National Vaccine Advisory Committee: In 
accordance with the charter, persons nominated for appointment as 
members of the NVAC should be among authorities knowledgeable in areas 
related to vaccine safety, vaccine effectiveness, and vaccine supply. 
In order to enhance the diversity of expertise included in Committee 
discussions, NVPO is seeking nominations of individuals to serve on the 
National Vaccine Advisory Committee as public members in the following 
disciplines/topic areas:
     Vaccine research and development, vaccine clinical trials, 
and vaccine regulatory science;
     vaccine safety and post-marketing surveillance;
     vaccine access and financing;
     health information technologies and immunization 
information systems;
     immunization program implementation and management; and
     vaccine communications.
    How to submit nominations: Nominations should be typewritten. The 
following information should be included in the package of material 
submitted for each individual being nominated for consideration: (1) A 
letter of nomination that clearly states the name and affiliation of 
the nominee, the basis for the nomination (i.e., specific attributes 
which qualify the nominee for service in this capacity); and a 
statement that the nominee is willing to serve as a member of the 
Committee (2) the nominator's name, address, and daytime telephone 
number, home and/or work address, telephone number, and email address; 
(3) a current copy of the nominee's curriculum vitae (no longer than 
ten pages); and (4) a short biographical sketch (no more than 350 
words). All required documentation must be received in order for a 
nomination to be considered.
    Please note that nominees will not receive updates on the status of 
their nomination. Information on nominees appointed to the Committee by 
the Department will be posted to the NVAC website at http://www.hhs.gov/nvpo/nvac/members/index.html.
    Individuals can nominate themselves for consideration of 
appointment to the Committee. All nominations must include the required 
information. Incomplete nominations will not be processed for 
consideration. The names of federal employees should not be nominated 
for consideration of appointment to this Committee.
    The Department makes every effort to ensure that the membership of 
HHS federal advisory committees is fairly balanced in terms of points 
of view represented and the committee's function. Every effort is made 
that a broad representation of geographic areas, gender, ethnic and 
minority groups, and the disabled are given consideration for 
membership on HHS federal advisory committees. Appointment to this 
Committee shall be made without discrimination on the basis of age, 
race, ethnicity, gender, sexual orientation, disability, and cultural, 
religious, or socioeconomic status.
    Individuals appointed to serve as public members of federal 
advisory committees are classified as special government employees 
(SGEs). SGEs are government employees for purposes of the conflict of 
interest laws. Therefore, individuals appointed to serve as public 
members of NVAC are subject to an ethics review. The ethics review is 
conducted to determine if the individual has any interests and/or 
activities in the private sector that may conflict with performance of 
their official duties as a member of the NVAC. Individuals appointed to 
serve as public members of the NVAC will be required to disclose 
information regarding financial holdings, consultancies, research 
grants and/or contracts, and the absence of an appearance of a loss of 
impartiality.

    Dated: March 30, 2018.
Roula Sweis,
Deputy Director, National Vaccine Program Office.
[FR Doc. 2018-06890 Filed 4-3-18; 8:45 am]
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                                                                           Federal Register / Vol. 83, No. 65 / Wednesday, April 4, 2018 / Notices                                          14463

                                             May 21, 2018, from 1:00 p.m. to 3:00                    leaders of tribal governments and their               Advisory Committee Act (FACA).
                                               p.m.                                                  designated representatives. Designees                 Management and support of the NVAC
                                             June 13, 2018, from 1:00 p.m. to 3:00                   must have a letter from the tribal                    and its activities are the responsibility
                                               p.m.                                                  government authorizing them to                        of the NVPO.
                                             August 6, 2018, from 1:00 p.m. to 3:00                  represent the tribe. Tribal governments                  The NVAC serves an advisory role,
                                               p.m.                                                  must submit the designee letter at least              providing recommendations to the
                                             October 2018, Date and time to be                       3 days in advance of the consultation                 Assistant Secretary for Health in his/her
                                               determined                                            sessions to Angie Godfrey at                          capacity as the Director of the National
                                             November 2018, Date and time to be                      Angie.Godfrey@acf.hhs.gov. Other                      Vaccine Program, on matters related to
                                               determined                                            representatives of tribal organizations               the Program’s responsibilities.
                                                                                                     and Native non-profit organizations are               Specifically, the Committee studies and
                                             ADDRESSES:
                                                                                                     welcome to attend as observers.                       recommends ways to encourage the
                                             • May 2, 2018—Grand Casino Hinckley,                       A detailed report of each consultation             availability of an adequate supply of
                                               777 Lady Luck Dr., Hinckley, MN                       session will be prepared and made                     safe and effective vaccination products
                                               55037                                                 available within 45 days of the                       in the United States; recommends
                                             • May 21, 2018—The University Union,                    consultation sessions to all tribal                   research priorities and other measures
                                               Union WELL Inc., Sacramento State,                    governments receiving funds for Head                  to enhance the safety and efficacy of
                                               6000 J Street, Sacramento, CA 95819–                  Start and Early Head Start programs.                  vaccines. The Committee also advises
                                               6017                                                  Tribes wishing to submit written                      the Assistant Secretary for Health in the
                                             • June 13, 2018—Sheraton Music City,                    testimony for the report should send                  implementation of Sections 2102 and
                                               777 Mcgavock Pike, Nashville, TN                      testimony to Angie Godfrey at                         2103 of the PHS Act; and identifies
                                             • August 6, 2018—Northern Quest                         Angie.Godfrey@acf.hhs.gov either prior                annually the most important areas of
                                               Hotel and Casino, 100 N Hayford Rd.,                  to each consultation session or within                government and non-government
                                               Airway Heights, WA 99001 (near                        30 days after each meeting. OHS will                  cooperation that should be considered
                                               Spokane airport)                                      summarize oral testimony and                          in implementing Sections 2102 and
                                             • October 2018—Anchorage, AK                            comments from the consultation                        2103 of the PHS Act.
                                               (Location to be provided at a later                   sessions in each report without                       DATES: All nominations for membership
                                               date)                                                 attribution, along with topics of concern             on the Committee must be received no
                                             • November 2018—Albuquerque, NM                         and recommendations.                                  later than 5:00 p.m. EDT on May 4,
                                               (Location to be provided at a later                                                                         2018, to the address listed below.
                                                                                                      Dated: March 20, 2018.
                                               date)
                                                                                                     Ann Linehan,                                          ADDRESSES: Nominations should be
                                             FOR FURTHER INFORMATION CONTACT:                        Acting Director, Office of Head Start.                emailed to nvac@hhs.gov.
                                             Angie Godfrey, Regional Program                         [FR Doc. 2018–06891 Filed 4–3–18; 8:45 am]            FOR FURTHER INFORMATION CONTACT:
                                             Manager, Region XI/AIAN, Office of                      BILLING CODE 4184–40–P                                National Vaccine Program Office,
                                             Head Start, email Angie.Godfrey@                                                                              Department of Health and Human
                                             acf.hhs.gov, or phone (202) 205–5811.                                                                         Services, 200 Independence Avenue
                                             Additional information and online                       DEPARTMENT OF HEALTH AND                              SW, Room 715–H, Washington, DC
                                             meeting registration will be available at               HUMAN SERVICES                                        20201; (202) 690–5566; nvac@hhs.gov.
                                             http://eclkc.ohs.acf.hhs.gov/hslc/hs/                                                                            A copy of the committee charter
                                             calendar/tc2018.                                        Solicitation of Nominations for                       which includes the NVAC’s structure
                                             SUPPLEMENTARY INFORMATION: In                           Membership on the National Vaccine                    and functions as well as a list of the
                                             accordance to the Improving Head Start                  Advisory Committee                                    current membership can be obtained by
                                             for School Readiness Act of 2007, Public                AGENCY:  National Vaccine Program                     accessing the NVAC website at: http://
                                             Law 110–134 [42 U.S.C. 9835, Section                    Office, Office of the Assistant Secretary             www.hhs.gov/nvpo/nvac/index.html.
                                             640(l)(4)], ACF announces OHS tribal                    for Health, Office of the Secretary,                  SUPPLEMENTARY INFORMATION:
                                             consultations for leaders of tribal                     Department of Health and Human                          Committee Function, Qualifications,
                                             governments operating Head Start and                    Services.                                             and Information Required: As part of an
                                             Early Head Start programs. The agenda                   ACTION: Notice.
                                                                                                                                                           ongoing effort to enhance deliberations
                                             for the scheduled OHS tribal                                                                                  and discussions with the public on
                                             consultations in Hinckley, Minnesota;                                                                         vaccine and immunization policy,
                                                                                                       Authority: 42 U.S.C. 300aa–5, Section 2105
                                             Sacramento, California; Nashville,                      of the Public Health Service (PHS) Act, as
                                                                                                                                                           nominations are being sought for
                                             Tennessee; Spokane, Washington;                         amended. The National Vaccine Advisory                interested individuals to serve on the
                                             Anchorage, Alaska; and Albuquerque,                     Committee is governed by the provisions of            NVAC. Committee members provide
                                             New Mexico will be organized around                     Public Law 92–463, as amended (5 U.S.C.               peer review, consultation, advice, and
                                             the statutory purposes of Head Start                    Appendix 2), which sets forth standards for           recommendations to the Assistant
                                             tribal consultations related to meeting                 the formation and use of advisory                     Secretary for Health, in his/her capacity
                                             the needs of American Indian and                        committees.                                           as the Director of the National Vaccine
                                             Alaska Native children and families,                    SUMMARY:   The National Vaccine                       Program, on matters related to the
                                             taking into consideration funding                       Program Office (NVPO), a program                      Program’s responsibilities. Individuals
                                             allocations, distribution formulas, and                 office within the Office of the Assistant             selected for appointment to the NVAC
                                             other issues affecting the delivery of                  Secretary for Health, Department of                   will serve as voting members. The
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                                             Head Start services in their geographic                 Health and Human Services (HHS), is                   NVAC consists of 17 voting members:
                                             locations. In addition, OHS will share                  soliciting nominations of qualified                   15 public members, including the Chair,
                                             actions taken and in progress to address                candidates to be considered for                       and two representative members.
                                             the issues and concerns raised in the                   appointment as public members to the                  Individuals selected for appointment to
                                             2017 OHS Tribal Consultations.                          National Vaccine Advisory Committee                   the NVAC can be invited to serve terms
                                                The consultation sessions will be                    (NVAC). The activities of this                        of up to four years. Selection of
                                             conducted with elected or appointed                     Committee are governed by the Federal                 members is based on candidates’


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                                             14464                         Federal Register / Vol. 83, No. 65 / Wednesday, April 4, 2018 / Notices

                                             qualifications to contribute to the                        Expertise sought for the National                  represented and the committee’s
                                             accomplishment of NVAC’s objectives.                    Vaccine Advisory Committee: In                        function. Every effort is made that a
                                             Interested candidates should                            accordance with the charter, persons                  broad representation of geographic
                                             demonstrate a willingness to commit                     nominated for appointment as members                  areas, gender, ethnic and minority
                                             time to NVAC activities and the ability                 of the NVAC should be among                           groups, and the disabled are given
                                             to work constructively and effectively                  authorities knowledgeable in areas                    consideration for membership on HHS
                                             on committees.                                          related to vaccine safety, vaccine                    federal advisory committees.
                                                Public Members: Public members are                   effectiveness, and vaccine supply. In                 Appointment to this Committee shall be
                                             individuals who are appointed to the                    order to enhance the diversity of                     made without discrimination on the
                                             NVAC to exercise their own                              expertise included in Committee                       basis of age, race, ethnicity, gender,
                                             independent best judgment on behalf of                  discussions, NVPO is seeking                          sexual orientation, disability, and
                                             the government. It is expected that                     nominations of individuals to serve on                cultural, religious, or socioeconomic
                                             public members will discuss and                         the National Vaccine Advisory                         status.
                                             deliberate in a manner that is free from                Committee as public members in the                      Individuals appointed to serve as
                                             conflicts of interest. Public members to                following disciplines/topic areas:                    public members of federal advisory
                                             the NVAC shall be selected from                            • Vaccine research and development,                committees are classified as special
                                             individuals who are engaged in vaccine                  vaccine clinical trials, and vaccine                  government employees (SGEs). SGEs are
                                             research or the manufacture of vaccines,                regulatory science;                                   government employees for purposes of
                                             or who are physicians, members of                          • vaccine safety and post-marketing                the conflict of interest laws. Therefore,
                                             parent organizations concerned with                     surveillance;                                         individuals appointed to serve as public
                                             immunizations, representatives of state                    • vaccine access and financing;                    members of NVAC are subject to an
                                             or local health agencies, or public health                 • health information technologies and              ethics review. The ethics review is
                                             organizations.                                          immunization information systems;                     conducted to determine if the
                                                Representative Members:                                 • immunization program                             individual has any interests and/or
                                             Representative members are individuals                  implementation and management; and                    activities in the private sector that may
                                             who are appointed to the NVAC to                           • vaccine communications.                          conflict with performance of their
                                             provide the views of industry or a                         How to submit nominations:                         official duties as a member of the
                                             special interest group. While they may                  Nominations should be typewritten. The                NVAC. Individuals appointed to serve
                                             be experts in various topic areas                       following information should be                       as public members of the NVAC will be
                                             discussed by the Committee, they                        included in the package of material                   required to disclose information
                                             should not present their own                            submitted for each individual being                   regarding financial holdings,
                                             viewpoints, but rather those of the                     nominated for consideration: (1) A letter             consultancies, research grants and/or
                                             industry or special interest group they                 of nomination that clearly states the                 contracts, and the absence of an
                                             represent. NVAC representative                          name and affiliation of the nominee, the              appearance of a loss of impartiality.
                                             members shall serve specifically to                     basis for the nomination (i.e., specific
                                                                                                                                                             Dated: March 30, 2018.
                                             represent the viewpoints or perspectives                attributes which qualify the nominee for
                                                                                                     service in this capacity); and a statement            Roula Sweis,
                                             of the vaccine manufacturing industry
                                             or groups engaged in vaccine research or                that the nominee is willing to serve as               Deputy Director, National Vaccine Program
                                                                                                     a member of the Committee (2) the                     Office.
                                             the manufacture of vaccines.
                                                This announcement is to solicit                      nominator’s name, address, and daytime                [FR Doc. 2018–06890 Filed 4–3–18; 8:45 am]
                                             nominations of qualified candidates to                  telephone number, home and/or work                    BILLING CODE 4150–44–P
                                             fill positions in the public and                        address, telephone number, and email
                                             representative member category of the                   address; (3) a current copy of the
                                             NVAC, including positions that are                      nominee’s curriculum vitae (no longer                 DEPARTMENT OF HEALTH AND
                                             scheduled to be vacated during the 2019                 than ten pages); and (4) a short                      HUMAN SERVICES
                                             calendar year. Applications received in                 biographical sketch (no more than 350                 National Institutes of Health
                                             response and not appointed may also be                  words). All required documentation
                                             considered for future vacancies that                    must be received in order for a                       Center for Scientific Review; Notice of
                                             occur.                                                  nomination to be considered.                          Closed Meeting
                                                Travel reimbursement and                                Please note that nominees will not
                                             compensation for services provided to                   receive updates on the status of their                  Pursuant to section 10(d) of the
                                             the committee: All NVAC members are                     nomination. Information on nominees                   Federal Advisory Committee Act, as
                                             authorized to receive the prescribed per                appointed to the Committee by the                     amended, notice is hereby given of the
                                             diem allowance and reimbursement for                    Department will be posted to the NVAC                 following meeting.
                                             travel expenses that are incurred to                    website at http://www.hhs.gov/nvpo/                     The meeting will be closed to the
                                             attend meetings and conduct authorized                  nvac/members/index.html.                              public in accordance with the
                                             NVAC-related business, in accordance                       Individuals can nominate themselves                provisions set forth in sections
                                             with standard government travel                         for consideration of appointment to the               552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                             regulations. Members appointed to the                   Committee. All nominations must                       as amended. The grant applications and
                                             NVAC as public members (see                             include the required information.                     the discussions could disclose
                                             definition above) also are authorized to                Incomplete nominations will not be                    confidential trade secrets or commercial
                                             receive a stipend for services provided                 processed for consideration. The names                property such as patentable material,
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                                             at public meetings of the Committee. All                of federal employees should not be                    and personal information concerning
                                             other services that are performed by the                nominated for consideration of                        individuals associated with the grant
                                             public members outside the Committee                    appointment to this Committee.                        applications, the disclosure of which
                                             meetings shall be provided without                         The Department makes every effort to               would constitute a clearly unwarranted
                                             compensation. Representative members                    ensure that the membership of HHS                     invasion of personal privacy.
                                             (see definition above) will serve without               federal advisory committees is fairly                   Name of Committee: Center for Scientific
                                             compensation.                                           balanced in terms of points of view                   Review Special Emphasis Panel; Member



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Document Created: 2018-11-01 09:11:22
Document Modified: 2018-11-01 09:11:22
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.
DatesAll nominations for membership on the Committee must be received
ContactNational Vaccine Program Office, Department of Health and Human Services, 200 Independence Avenue SW, Room 715-H, Washington, DC 20201; (202) 690-5566; [email protected]
FR Citation83 FR 14463 

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