81 FR 26238 - Solicitation of Nominations for Membership on the National Vaccine Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 84 (May 2, 2016)

Page Range		26238-26240
FR Document		2016-10205

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 NVAC. The activities of this Committee are governed by the Federal Advisory Committee Act (FACA). Management and support services 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; and 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 81 Issue 84 (Monday, May 2, 2016)

[Federal Register Volume 81, Number 84 (Monday, May 2, 2016)]
[Notices]
[Pages 26238-26240]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-10205]


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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.

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

AUTHORITY: 42 U.S.C. 300aa-5, Section 2105 of the Public Health Service 
(PHS) Act, as amended. The National Vaccine

[[Page 26239]]

Advisory Committee (NVAC) 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 
NVAC. The activities of this Committee are governed by the Federal 
Advisory Committee Act (FACA). Management and support services 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; and 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 June 1, 2016, to the address listed 
below.

ADDRESSES: Hardcopy nominations should be mailed or delivered to: Bruce 
Gellin, M.D., M.P.H., Executive Secretary, NVAC, Office of the 
Assistant Secretary for Health, Department of Health and Human 
Services, 200 Independence Avenue SW., Room 715-H, Washington, DC 
20201. Electronic nominations should be emailed to [email protected].

FOR FURTHER INFORMATION CONTACT: Jennifer Gordon, Ph.D., Alternate 
Designated Federal Official, NVAC; Science Advisor, National Vaccine 
Program Office, Department of Health and Human Services, 200 
Independence Avenue SW., Room 733G, Washington, DC 20201; (202) 260-
6619; [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 contacting Dr. Gordon or by accessing the NVAC Web site at: 
www.hhs.gov/nvpo/nvac.

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' 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 member category of the NVAC, including 
positions that are scheduled to be vacated during the 2016 calendar 
year.
    Travel reimbursement and compensation for services provided to the 
committee: All voting NVAC members, public and representatives, 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 
NVAC 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;
     vaccine communications;
    How to submit nominations: Nominations should be typewritten. The 
following information is required to 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 copy of the nominee's current curriculum vitae (no 
longer than ten pages); and (4) a short biographical

[[Page 26240]]

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 Web site (http://www.hhs.gov/nvpo/nvac/roster/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: April 25, 2016.
Bruce Gellin,
Executive Secretary, National Vaccine Advisory Committee Deputy 
Assistant Secretary for Health, Director, National Vaccine Program 
Office.
[FR Doc. 2016-10205 Filed 4-29-16; 8:45 am]
BILLING CODE 4150-44-P

26238 Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Notices

regarding the burden estimate, below, or broad membership, and (2) develop a to understand the contexts in which the
any other aspect of the ICR. community plan for improving Guide is most effective.
DATES: Comments on the ICR must be adolescent health and well-being that Likely Respondents—Qualitative data
received on or before July 1, 2016. includes multi-impact strategies. To will be collected through semi-
ADDRESSES: Submit your comments to understand whether and how structured telephone interviews and
Information.CollectionClearance@ community leaders are able to use the through focus groups. Telephone
hhs.gov or by calling (202) 690–6162. Guide to achieve these two goals, OASH interviews will be conducted with
FOR FURTHER INFORMATION CONTACT: needs information about the Guide’s community leaders (Community Leader
Information Collection Clearance staff, utility and effectiveness. The evaluation Interview) in the five pilot sites to
Information.CollectionClearance@ of the Second Decade Project explore how the use of the Guide
hhs.gov or (202) 690–6162. Community Planning Guide (‘‘the supported key leaders in their
SUPPLEMENTARY INFORMATION: When evaluation’’) is intended to support the development of a diverse coalition and
submitting comments or requesting goals of OASH’s Second Decade Project educating the community about issues
information, please include the of helping community leaders
facing adolescents. Focus groups will be
document identifier HHS–OS–0990– incorporate the needs of children,
conducted with coalition members
New—60D for reference. adolescents and young adults in
(Coalition Member Focus Groups) from
Information Collection Request Title: community growth and development
the five pilot sites to assess how the
Evaluation of the Second Decade Project plans, and to improve outcomes of
Guide facilitated the work of the
Community Planning Guide Abstract: young adults and adolescents. Five
coalition to develop a comprehensive
The Office of the Assistant Secretary for communities will participate in the
community plan that addresses
Health (OASH) is requesting approval piloting and evaluation of the Guide.
critically important adolescent health
from the Office of Management and The evaluation will provide OASH with
issues.
Budget (OMB) for an evaluation of the critical information regarding the
Second Decade Project Community components of the Guide that Quantitative data will be collected
Planning Guide. community leaders found most useful through Web-based surveys with
OASH has a long history of and effective in accomplishing their coalition members from the five
collaborating with communities to goals of improving adolescent health communities and with secondary
improve adolescent health outcomes. To and wellbeing; the compilation and stakeholders—specifically, adolescent
further help communities build an inclusiveness of the coalitions health experts and state/local health
environment that promotes adolescent implementing the Guide; and the department officials—selected by
health, OASH recently developed demographic and environmental context OASH. The Coalition Assessment
Promoting Health and Healthy of these communities. While secondary Survey will assess coalition members’
Development in the Second Decade of data will be collected from sources such perspectives on the usefulness and ease
Life: A Planning Guide for Communities as the U.S. Census Bureau American of implementing the Guide. The
(‘‘the Guide’’). The purpose of the Guide Community Survey and Youth Risk Secondary Stakeholder Survey will
is to provide an easy to follow tool that Behavior and National Health Interview engage Adolescent Health researchers
community leaders can use to (1) Surveys, these sources do not provide and practitioners to garner additional
establish a community coalition with nuanced information needed by OASH feedback and assessment of the Guide.

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
Number of Hours per Total burden
Form name responses per
respondents response hours
respondent

Community Leader Interview (CLI) ................................................................ 50 1 1 50
Coalition Member Focus Group (CFG) ......................................................... 80 1 1 80
Coalition Assessment Survey (CAS) ............................................................. 250 1 .25 63
Secondary Stakeholder Survey (SSS) .......................................................... 50 1 .5 25

Total ........................................................................................................ 430 .......................... ........................ 218

OASH specifically requests comments technology to minimize the information DEPARTMENT OF HEALTH AND
on (1) the necessity and utility of the collection burden. HUMAN SERVICES
proposed information collection for the
Terry S. Clark, Solicitation of Nominations for
proper performance of the agency’s
functions, (2) the accuracy of the Asst. Information Collection Clearance Membership on the National Vaccine
Officer. Advisory Committee
estimated burden, (3) ways to enhance
[FR Doc. 2016–10199 Filed 4–29–16; 8:45 am]
the quality, utility, and clarity of the AGENCY: National Vaccine Program
information to be collected, and (4) the BILLING CODE 4150–28–P
Office, Office of the Assistant Secretary
use of automated collection techniques
srobinson on DSK5SPTVN1PROD with NOTICES

for Health, Office of the Secretary,
or other forms of information Department of Health and Human
Services.
ACTION: Notice.

AUTHORITY: 42 U.S.C. 300aa–5, Section
2105 of the Public Health Service (PHS)
Act, as amended. The National Vaccine

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26240 Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Notices

sketch (no more than 350 words). All DEPARTMENT OF HEALTH AND Career Development Awards for Scientists
required documentation must be HUMAN SERVICES and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
received in order for a nomination to be
National Institutes of Health Training; 93.273, Alcohol Research Programs;
considered. Please note that nominees 93.891, Alcohol Research Center Grants;
will not receive updates on the status of 93.701, ARRA Related Biomedical Research
National Institute on Alcohol Abuse
their nomination. Information on and Research Support Awards., National
and Alcoholism; Notice of Meeting Institutes of Health, HHS)
nominees appointed to the Committee
by the Department will be posted to the Pursuant to section 10(d) of the Dated: April 26, 2016.
NVAC Web site (http://www.hhs.gov/ Federal Advisory Committee Act, as Melanie J. Gray,
nvpo/nvac/roster/index.html). amended (5 U.S.C. App.), notice is Program Analyst, Office of Federal Advisory
Individuals can nominate themselves hereby given of a meeting of the Committee Policy.
for consideration of appointment to the National Advisory Council on Alcohol [FR Doc. 2016–10145 Filed 4–29–16; 8:45 am]
Committee. All nominations must Abuse and Alcoholism. BILLING CODE 4140–01–P
include the required information. The meeting will be open to the
Incomplete nominations will not be public as indicated below, with
processed for consideration. The names attendance limited to space available. DEPARTMENT OF HEALTH AND
of federal employees should not be Individuals who plan to attend and HUMAN SERVICES
nominated for consideration of need special assistance, such as sign
appointment to this Committee. language interpretation or other National Institutes of Health
reasonable accommodations, should
The Department makes every effort to notify the Contact Person listed below National Cancer Institute; Notice of
ensure that the membership of HHS in advance of the meeting. Closed Meetings
federal advisory committees is fairly The meeting will be closed to the Pursuant to section 10(d) of the
balanced in terms of points of view public in accordance with the Federal Advisory Committee Act, as
represented and the committee’s provisions set forth in sections amended (5 U.S.C. App.), notice is
function. Every effort is made that a 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., hereby given of the following meetings.
broad representation of geographic as amended. The grant applications and The meetings will be closed to the
areas, gender, ethnic and minority the discussions could disclose public in accordance with the
groups, and the disabled are given confidential trade secrets or commercial provisions set forth in sections
consideration for membership on HHS property such as patentable material, 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
federal advisory committees. and personal information concerning as amended. The grant applications/
Appointment to this Committee shall be individuals associated with the grant contract proposals and the discussions
made without discrimination on the applications, the disclosure of which could disclose confidential trade secrets
basis of age, race, ethnicity, gender, would constitute a clearly unwarranted or commercial property such as
sexual orientation, disability, and invasion of personal privacy. patentable material, and personal
cultural, religious, or socioeconomic Name of Committee: National Advisory information concerning individuals
status. Council on Alcohol Abuse and Alcoholism. associated with the grant applications/
Date: June 9, 2016. contract proposals, the disclosure of
Individuals appointed to serve as Closed: 9:00 a.m. to 10:00 a.m.
public members of federal advisory which would constitute a clearly
Agenda: To review and evaluate grant
committees are classified as special unwarranted invasion of personal
applications.
government employees (SGEs). SGEs are Place: National Institutes of Health, privacy.
government employees for purposes of Terrace Conference Rooms, 5635 Fishers Name of Committee: National Cancer
the conflict of interest laws. Therefore, Lane, Rockville, MD 20892. Institute Special Emphasis Panel;
individuals appointed to serve as public Open: 10:15 a.m. to 4:00 p.m. Development of Protein Standards.
Agenda: Presentations and other business Date: May 31, 2016.
members of NVAC are subject to an of the council. Time: 1:00 p.m. to 2:30 p.m.
ethics review. The ethics review is Place: National Institutes of Health, Agenda: To review and evaluate contract
conducted to determine if the Terrace Conference Rooms, 5635 Fishers proposals.
individual has any interests and/or Lane, Rockville, MD 20892. Place: National Cancer Institute Shady
activities in the private sector that may Contact Person: Abraham P. Bautista, Grove, 9609 Medical Center Drive, Room
conflict with performance of their Ph.D., Executive Secretary, National Institute 7W114, Rockville, MD 20850 (Telephone
official duties as a member of the on Alcohol Abuse & Alcoholism, National Conference Call).
Institutes of Health, 5635 Fishers Lane, Room Contact Person: Jeffrey E. DeClue, Ph.D.,
NVAC. Individuals appointed to serve 2085, Rockville, MD 20852, 301–443–9737, Scientific Review Officer, Research
as public members of the NVAC will be bautista@mail.nih.gov. Technology and Contract Review Branch,
required to disclose information Any interested person may file written Division of Extramural Activities, National
regarding financial holdings, comments with the committee by forwarding Cancer Institute, 9609 Medical Center Drive,
consultancies, research grants and/or the statement to the Contact Person listed on Room 7W238, Bethesda, MD 20892–9750,
contracts, and the absence of an this notice. The statement should include the 240–276–6371, decluej@mail.nih.gov.
appearance of a loss of impartiality. name, address, telephone number and when Name of Committee: National Cancer
applicable, the business or professional Institute Special Emphasis Panel; Member
Dated: April 25, 2016. affiliation of the interested person. Conflict SEP.
srobinson on DSK5SPTVN1PROD with NOTICES

Bruce Gellin, Information is also available on the Date: June 27, 2016.
Institute’s/Center’s home page: http:// Time: 11:00 a.m. to 12:00 p.m.
Executive Secretary, National Vaccine www.niaaa.nih.gov/AboutNIAAA/
Advisory Committee Deputy Assistant Agenda: To review and evaluate grant
AdvisoryCouncil/Pages/default.aspx, where applications.
Secretary for Health, Director, National an agenda and any additional information for Place: National Cancer Institute Shady
Vaccine Program Office. the meeting will be posted when available. Grove, 9609 Medical Center Drive, Room
[FR Doc. 2016–10205 Filed 4–29–16; 8:45 am] (Catalogue of Federal Domestic Assistance 7W530, Rockville, MD 20850 (Telephone
BILLING CODE 4150–44–P Program Nos. 93.271, Alcohol Research Conference Call).

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Document Created: 2016-04-30 13:35:15
Document Modified: 2016-04-30 13:35:15

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		All nominations for membership on the Committee must be received
Contact		Jennifer Gordon, Ph.D., Alternate Designated Federal Official, NVAC; Science Advisor, National Vaccine Program Office, Department of Health and Human Services, 200 Independence Avenue SW., Room 733G, Washington, DC 20201; (202) 260- 6619; [email protected]
FR Citation		81 FR 26238