81 FR 41316 - Advisory Commission on Childhood Vaccines; Request for Nominations for Voting Members

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 81, Issue 122 (June 24, 2016)

Page Range		41316-41317
FR Document		2016-14960

The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the Advisory Commission on Childhood Vaccines (ACCV). The ACCV was established by title XXI of the Public Health Service Act (the Act), as enacted by Public Law (Pub. L.) 99-660 and as subsequently amended, and advises the Secretary of Health and Human Services (the Secretary) on issues related to implementation of the National Vaccine Injury Compensation Program (VICP).

Federal Register, Volume 81 Issue 122 (Friday, June 24, 2016)

[Federal Register Volume 81, Number 122 (Friday, June 24, 2016)]
[Notices]
[Pages 41316-41317]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-14960]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Advisory Commission on Childhood Vaccines; Request for 
Nominations for Voting Members

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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SUMMARY: The Health Resources and Services Administration (HRSA) is 
requesting nominations to fill vacancies on the Advisory Commission on 
Childhood Vaccines (ACCV). The ACCV was established by title XXI of the 
Public Health Service Act (the Act), as enacted by Public Law (Pub. L.) 
99-660 and as subsequently amended, and advises the Secretary of Health 
and Human Services (the Secretary) on issues related to implementation 
of the National Vaccine Injury Compensation Program (VICP).

DATES: The agency will receive nominations on a continuous basis.

ADDRESSES: All nominations are to be submitted to the Director, 
Division of Injury Compensation Programs, Healthcare Systems Bureau 
(HSB), HRSA, 5600 Fishers Lane, Room 08N146B, Rockville, Maryland 
20857. Nominations submitted electronically should be submitted to 
[email protected] or [email protected].

FOR FURTHER INFORMATION CONTACT: Ms. Annie Herzog, Principal Staff 
Liaison, Division of Injury Compensation Programs, HSB, HRSA, at (301) 
443-6634 or email: [email protected].

SUPPLEMENTARY INFORMATION: Under the authorities that established the 
ACCV, the Federal Advisory Committee Act of October 6, 1972, (Pub. L. 
92-463) and section 2119 of the Act, 42 U.S.C.

[[Page 41317]]

300aa-19, as added by Pub. L. 99-660 and amended, HRSA is requesting 
nominations for voting members of the ACCV.
    The ACCV advises the Secretary on the implementation of the VICP. 
Other activities of the ACCV include: Recommending changes in the 
Vaccine Injury Table, at its own initiative or as the result of the 
filing of a petition; advising the Secretary in implementing section 
2127 of the Act regarding the need for childhood vaccination products 
that result in fewer or no significant adverse reactions; surveying 
federal, state, and local programs and activities related to gathering 
information on injuries associated with the administration of childhood 
vaccines, including the adverse reaction reporting requirements of 
section 2125(b) of the Act; advising the Secretary on the methods of 
obtaining, compiling, publishing, and using credible data related to 
the frequency and severity of adverse reactions associated with 
childhood vaccines; consulting on the development or revision of 
Vaccine Information Statements; and recommending to the Director of the 
National Vaccine Program research related to vaccine injuries which 
should be conducted to carry out the VICP.
    The ACCV consists of nine voting members appointed by the Secretary 
as follows: (1) Three health professionals, who are not employees of 
the United States Government, and who have expertise in the health care 
of children, the epidemiology, etiology, and prevention of childhood 
diseases, and the adverse reactions associated with vaccines, of whom 
at least two shall be pediatricians; (2) three members from the general 
public, of whom at least two shall be legal representatives (parents or 
guardians) of children who have suffered a vaccine-related injury or 
death; and (3) three attorneys, of whom at least one shall be an 
attorney whose specialty includes representation of persons who have 
suffered a vaccine-related injury or death, and of whom one shall be an 
attorney whose specialty includes representation of vaccine 
manufacturers. In addition, the Director of the National Institutes of 
Health, the Assistant Secretary for Health, the Director of the Centers 
for Disease Control and Prevention, and the Commissioner of the Food 
and Drug Administration (or the designees of such officials) serve as 
nonvoting ex officio members.
    The Department of Health and Human Services (HHS or Department) 
will consider nominations of all qualified individuals with a view to 
ensure that the ACCV includes the areas of subject matter expertise 
noted above. As indicated above, at least two of the three ACCV members 
of the general public must be legal representatives (parents or 
guardians) of children who have suffered a vaccine-related injury or 
death. Because those members must be the legal representatives of 
children who have suffered a vaccine-related injury or death, to be 
considered for appointment to the ACCV in that category there must have 
been a finding (i.e., a decision) by the U.S. Court of Federal Claims 
or a civil court that a VICP-covered vaccine caused, or was presumed to 
have caused, the represented child's injury or death. Based on a 
recommendation made by the ACCV, the Secretary will consider having a 
health professional with expertise in obstetrics as one of the members 
of the general public.
    ACCV members are appointed as Special Government Employees. As 
such, they are covered by the federal ethics rules, including the 
criminal conflict of interest statutes governing executive branch 
employees. For example, an ACCV member may be prohibited from 
discussions about making changes to the Vaccine Injury Table and 
Vaccine Information Statements for the Hepatitis B vaccine if he/she or 
his/her spouse owns stock valued above a certain amount in companies 
which manufacturer this vaccine, affecting their own pecuniary 
interests--including interests imputed to them. To evaluate possible 
conflicts of interest, potential candidates will be asked to fill out 
the Confidential Financial Disclosure Report, OGE Form 450, to provide 
detailed information concerning financial interests, consultancies, 
research grants, and/or contracts that might be affected by 
recommendations made by the ACCV.
    Interested persons may nominate one or more qualified persons for 
membership on the ACCV. Nominations shall state that the nominee is 
willing to serve as a member of the ACCV. Nominees will be invited to 
serve a 3-year term beginning the date of appointment. A nomination 
package should be submitted as hard copy, email communication, or 
compact disk. A nomination package should include the following 
information for each nominee: (1) A letter of nomination stating the 
name, affiliation, and contact information for the nominee, the basis 
for the nomination (i.e., what specific attributes, perspectives, and/
or skills does the individual possess that would benefit the workings 
of the ACCV) and the nominee's field(s) of expertise; (2) a 
biographical sketch of the nominee and a copy of his/her curriculum 
vitae; and (3) the name, address, daytime telephone number, and email 
address at which the nominator can be contacted. Nomination packages 
will be collected and retained to create a pool of possible future ACCV 
voting members. When a vacancy occurs, nomination packages from the 
appropriate category will be reviewed and nominees may be contacted.
    HHS strives to ensure that the membership of the HHS Federal 
Advisory Committee is fairly balanced in terms of points of view 
represented and the committee's function. Appointment to the ACCV shall 
be made without discrimination on basis of age, race, ethnicity, 
gender, sexual orientation, disability, and cultural, religious, or 
socioeconomic status. The Department encourages nominations of 
qualified candidates from all groups and locations.

Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-14960 Filed 6-23-16; 8:45 am]
 BILLING CODE 4165-15-P

Federal Register / Vol. 81, No. 122 / Friday, June 24, 2016 / Notices 41317

300aa–19, as added by Pub. L. 99–660 the ACCV includes the areas of subject a copy of his/her curriculum vitae; and
and amended, HRSA is requesting matter expertise noted above. As (3) the name, address, daytime
nominations for voting members of the indicated above, at least two of the three telephone number, and email address at
ACCV. ACCV members of the general public which the nominator can be contacted.
The ACCV advises the Secretary on must be legal representatives (parents or Nomination packages will be collected
the implementation of the VICP. Other guardians) of children who have and retained to create a pool of possible
activities of the ACCV include: suffered a vaccine-related injury or future ACCV voting members. When a
Recommending changes in the Vaccine death. Because those members must be vacancy occurs, nomination packages
Injury Table, at its own initiative or as the legal representatives of children from the appropriate category will be
the result of the filing of a petition; who have suffered a vaccine-related reviewed and nominees may be
advising the Secretary in implementing injury or death, to be considered for contacted.
section 2127 of the Act regarding the appointment to the ACCV in that HHS strives to ensure that the
need for childhood vaccination category there must have been a finding membership of the HHS Federal
products that result in fewer or no (i.e., a decision) by the U.S. Court of Advisory Committee is fairly balanced
significant adverse reactions; surveying Federal Claims or a civil court that a in terms of points of view represented
federal, state, and local programs and VICP-covered vaccine caused, or was and the committee’s function.
activities related to gathering presumed to have caused, the Appointment to the ACCV shall be
information on injuries associated with represented child’s injury or death. made without discrimination on basis of
the administration of childhood Based on a recommendation made by age, race, ethnicity, gender, sexual
vaccines, including the adverse reaction the ACCV, the Secretary will consider orientation, disability, and cultural,
reporting requirements of section having a health professional with religious, or socioeconomic status. The
2125(b) of the Act; advising the expertise in obstetrics as one of the Department encourages nominations of
Secretary on the methods of obtaining, members of the general public. qualified candidates from all groups and
compiling, publishing, and using ACCV members are appointed as locations.
credible data related to the frequency Special Government Employees. As
and severity of adverse reactions such, they are covered by the federal Jason E. Bennett,
associated with childhood vaccines; ethics rules, including the criminal Director, Division of the Executive Secretariat.
consulting on the development or conflict of interest statutes governing [FR Doc. 2016–14960 Filed 6–23–16; 8:45 am]
revision of Vaccine Information executive branch employees. For BILLING CODE 4165–15–P
Statements; and recommending to the example, an ACCV member may be
Director of the National Vaccine prohibited from discussions about
Program research related to vaccine making changes to the Vaccine Injury DEPARTMENT OF HEALTH AND
injuries which should be conducted to Table and Vaccine Information HUMAN SERVICES
carry out the VICP. Statements for the Hepatitis B vaccine if
The ACCV consists of nine voting he/she or his/her spouse owns stock National Institutes of Health
members appointed by the Secretary as valued above a certain amount in National Cancer Institute; Notice of
follows: (1) Three health professionals, companies which manufacturer this Closed Meetings
who are not employees of the United vaccine, affecting their own pecuniary
States Government, and who have interests—including interests imputed Pursuant to section 10(d) of the
expertise in the health care of children, to them. To evaluate possible conflicts Federal Advisory Committee Act, as
the epidemiology, etiology, and of interest, potential candidates will be amended (5 U.S.C. App.), notice is
prevention of childhood diseases, and asked to fill out the Confidential hereby given of the following meetings.
the adverse reactions associated with Financial Disclosure Report, OGE Form The meetings will be closed to the
vaccines, of whom at least two shall be 450, to provide detailed information public in accordance with the
pediatricians; (2) three members from concerning financial interests, provisions set forth in sections
the general public, of whom at least two consultancies, research grants, and/or 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
shall be legal representatives (parents or contracts that might be affected by as amended. The grant applications/
guardians) of children who have recommendations made by the ACCV. contract proposals and the discussions
suffered a vaccine-related injury or Interested persons may nominate one could disclose confidential trade secrets
death; and (3) three attorneys, of whom or more qualified persons for or commercial property such as
at least one shall be an attorney whose membership on the ACCV. Nominations patentable material, and personal
specialty includes representation of shall state that the nominee is willing to information concerning individuals
persons who have suffered a vaccine- serve as a member of the ACCV. associated with the grant applications/
related injury or death, and of whom Nominees will be invited to serve a 3- contract proposals, the disclosure of
one shall be an attorney whose specialty year term beginning the date of which would constitute a clearly
includes representation of vaccine appointment. A nomination package unwarranted invasion of personal
manufacturers. In addition, the Director should be submitted as hard copy, email privacy.
of the National Institutes of Health, the communication, or compact disk. A Name of Committee: National Cancer
Assistant Secretary for Health, the nomination package should include the Institute Special Emphasis Panel HTLV.
Director of the Centers for Disease following information for each nominee: Date: July 15, 2016.
Control and Prevention, and the (1) A letter of nomination stating the Time: 11:30 a.m. to 3:00 p.m.
Commissioner of the Food and Drug name, affiliation, and contact Agenda: To review and evaluate contract
sradovich on DSK3GDR082PROD with NOTICES

Administration (or the designees of such information for the nominee, the basis proposals.
officials) serve as nonvoting ex officio for the nomination (i.e., what specific Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
members. attributes, perspectives, and/or skills
3W032/034, Rockville, MD 20850 (Telephone
The Department of Health and Human does the individual possess that would Conference Call).
Services (HHS or Department) will benefit the workings of the ACCV) and Contact Person: Kenneth L. Bielat, Ph.D.,
consider nominations of all qualified the nominee’s field(s) of expertise; (2) a Scientific Review Officer, Research and
individuals with a view to ensure that biographical sketch of the nominee and Technology and Contract Review Branch,

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Document Created: 2016-06-24 00:53:01
Document Modified: 2016-06-24 00:53:01

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		The agency will receive nominations on a continuous basis.
Contact		Ms. Annie Herzog, Principal Staff Liaison, Division of Injury Compensation Programs, HSB, HRSA, at (301) 443-6634 or email: [email protected]
FR Citation		81 FR 41316

81 FR 41316 - Advisory Commission on Childhood Vaccines; Request for Nominations for Voting Members

DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth Resources and Services Administration

Federal Register Volume 81, Issue 122 (June 24, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration