Solicitation of Nominations for Membership To Serve on the Advisory Committee on Heritable Disorders in Newborns and Children, 14866-14867 [2018-07005]
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Federal Register / Vol. 83, No. 67 / Friday, April 6, 2018 / Notices
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 vaccinerelated 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.
HHS 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.
Additionally, 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.
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19:21 Apr 05, 2018
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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 that 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 U.S. Office of
Government Ethics (OGE) 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 3year term beginning the date of
appointment. A nomination package
should be submitted as hard copy or
email communication and 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 at that time.
HHS strives to ensure that the
membership of the ACCV is balanced in
terms of points of view presented and
the committee’s function. Every effort is
made to ensure that the views of
women, all ethnic and racial groups,
and people with disabilities are
represented on HHS Federal Advisory
Committees and, therefore, HHS
encourages nominations of qualified
candidates from these groups. HHS also
encourages geographic diversity in the
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composition of the Committee.
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. HHS
encourages nominations of qualified
candidates from all groups and
locations.
Dated: March 30, 2018.
Lori A. Roche,
Acting Deputy, Division of the Executive
Secretariat.
[FR Doc. 2018–07007 Filed 4–5–18; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Nominations for
Membership To Serve on the Advisory
Committee on Heritable Disorders in
Newborns and Children
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Request for nominations.
AGENCY:
HRSA is seeking nominations
of qualified candidates to be considered
for appointment as members of the
Advisory Committee on Heritable
Disorders in Newborns and Children
(Committee). The Committee provides
advice, recommendations, and technical
information about aspects of heritable
disorders and newborn and childhood
screening to the Secretary of HHS.
HRSA is seeking nominations of
qualified candidates to fill up to three
positions on the Committee.
DATE: Written nominations for
membership on the Committee must be
received on or before April 30, 2018.
ADDRESSES: Nomination packages must
be submitted electronically as email
attachments to Alaina Harris, Genetic
Services Branch, Maternal and Child
Health Bureau (MCHB), HRSA,
AHarris@hrsa.gov.
FOR FURTHER INFORMATION CONTACT:
Alaina Harris. Address: MCHB, HRSA,
5600 Fishers Lane, Room 18W66,
Rockville, MD 20857; phone number:
(301) 443–0721; email: AHarris@
hrsa.gov. A copy of the Committee
Charter and list of the current
membership can be obtained by
accessing the Committee website at
www.hrsa.gov/advisory-committees/
heritable-disorders.
SUPPLEMENTARY INFORMATION: The
Committee was established in 2003 to
advise the Secretary of HHS regarding
newborn screening tests, technologies,
policies, guidelines, and programs for
SUMMARY:
E:\FR\FM\06APN1.SGM
06APN1
daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 67 / Friday, April 6, 2018 / Notices
effectively reducing morbidity and
mortality in newborns and children
having or at risk for heritable disorders.
In addition, the Committee provides
advice and recommendations to the
Secretary concerning the grants and
projects authorized under section 1109
of the PHSA and technical information
to develop policies and priorities for
grants, including those that will
enhance the ability of the state and local
health agencies to provide for newborn
and child screening, counseling and
health care services for newborns, and
children having or at risk for heritable
disorders.
The Committee reviews and reports
regularly on newborn and childhood
screening practices for heritable
disorders, recommends improvements
in the national newborn and childhood
heritable screening programs, and
recommends conditions for inclusion in
the Recommended Uniform Screening
Panel (RUSP). The Committee’s
recommendations regarding additional
conditions/inherited disorders for
screening that have been adopted by the
Secretary are included in the RUSP and
constitute part of the comprehensive
guidelines supported by HRSA pursuant
to section 2713 of the PHSA, codified at
42 U.S.C. 300gg–13. Under this
provision, non-grandfathered health
plans and group and individual health
insurance issuers are required to cover
screenings included in the HRSAsupported comprehensive guidelines
without charging a co-payment, coinsurance, or deductible for plan years
(i.e., in the individual market, policy
years) beginning on or after the date that
is one (1) year from the Secretary’s
adoption of the condition for screening.
Nominations: HRSA is requesting
nominations to fill up to three (3)
positions for voting members to serve on
the Committee. The Secretary appoints
committee members with the expertise
needed to fulfill the duties of the
Committee established under section
1111(b) of the PHSA, as amended by the
Newborn Screening Saves Lives
Reauthorization Act of 2014 (Act; 42
U.S.C. 300b–10(b)). Areas of expertise
include medical, technical, or scientific
professionals with special expertise in
the field of heritable disorders or in
providing screening, counseling, testing,
or specialty services for newborns and
children with, or at risk for having,
heritable disorders; and/or who have
expertise in ethics (e.g., bioethics) and
infectious diseases and who have
worked and published material in the
area of newborn screening; and/or are
members of the public having special
expertise about or concern with
heritable disorders; and/or
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19:21 Apr 05, 2018
Jkt 244001
representatives from such federal
agencies, public health constituencies,
and medical professional societies.
Interested applicants may self-nominate
or be nominated by another individual
or organization. Nominees must reside
in the United States.
Individuals selected for appointment
to the Committee will be invited to
serve for up to four (4) years. Members
who are not federal officers or
permanent federal employees are
appointed as special government
employees and receive a stipend and
reimbursement for per diem and travel
expenses incurred for attending
Committee meetings and/or conducting
other business on behalf of the
Committee, as authorized by section 5
U.S.C. 5703 for persons employed
intermittently in government service.
Members who are officers or employees
of the United States Government shall
not receive additional compensation for
service on the Committee, but receive
per diem and travel expenses incurred
for attending Committee meetings and/
or conducting other business on behalf
of the Committee.
The following information must be
included in the package of materials
submitted for each individual being
nominated for consideration: (1) A
statement that includes the name and
affiliation of the nominee and a clear
statement regarding the basis for the
nomination, including the area(s) of
expertise that may qualify a nominee for
service on the Committee, as described
above; (2) confirmation the nominee is
willing to serve as a member of the
Committee; (3) the nominee’s contact
information (include home address,
work address, daytime telephone
number, and an email address); and (4)
a current copy of the nominee’s
curriculum vitae. Nomination packages
may be submitted directly by the
individual being nominated or by the
person/organization recommending the
candidate.
HHS will endeavor to ensure that the
membership of the Committee is fairly
balanced in terms of points of view
represented and that individuals from a
broad representation of geographic
areas, gender, ethnic and minority
groups, as well as individuals with
disabilities, are considered for
membership. Appointments shall be
made without discrimination on the
basis of age, ethnicity, gender, sexual
orientation, and cultural, religious, or
socioeconomic status.
Individuals who are selected to be
considered for appointment will be
required to provide detailed information
regarding their financial holdings,
consultancies, and research grants or
PO 00000
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Fmt 4703
Sfmt 4703
14867
contracts. Disclosure of this information
is necessary in order to determine if the
selected candidate is involved in any
activity that may pose a potential
conflict with the official duties to be
performed as a member of the
Committee.
Authority: Section 1111 of the Public
Health Service Act (PHSA), as amended by
the Newborn Screening Saves Lives
Reauthorization Act of 2014 (42 U.S.C. 300b–
10). The Committee is governed by the
Federal Advisory Committee Act (FACA), as
amended (5 U.S.C. App.), and 41 CFR part
102–3, which set forth standards for the
formation and use of advisory committees.
Dated: March 30, 2018.
Lori A. Roche,
Acting Deputy Director, Division of the
Executive Secretariat.
[FR Doc. 2018–07005 Filed 4–5–18; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Interagency Coordinating Committee
on the Validation of Alternative
Methods; Notice of Public Meeting;
Request for Public Input
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The Interagency Coordinating
Committee on the Validation of
Alternative Methods (ICCVAM) will
hold a public forum to share
information and facilitate direct
communication of ideas and suggestions
from stakeholders. Interested persons
may attend in person or view the
meeting remotely by webcast. Time will
be set aside for questions and public
statements on the topics discussed.
Registration is requested for both public
attendance and oral statements, and
required for remote access. Information
about the meeting and registration are
available at https://ntp.niehs.nih.gov/go/
iccvamforum-2018.
DATES:
Meeting: May 24, 2018, 9:00 a.m. to
approximately 4:00 p.m. Eastern
Daylight Time (EDT).
Registration for Onsite Meeting:
Deadline is May 11, 2018.
Registration for Webcast: Deadline is
May 24, 2018.
Submission of Oral Public Statements:
Deadline is May 11, 2018.
ADDRESSES: Meeting Location: William
H. Natcher Conference Center, National
Institutes of Health, Bethesda, MD
20892. Meeting web page: The
SUMMARY:
E:\FR\FM\06APN1.SGM
06APN1
]]>Agencies
[Federal Register Volume 83, Number 67 (Friday, April 6, 2018)]
[Notices]
[Pages 14866-14867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07005]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Solicitation of Nominations for Membership To Serve on the
Advisory Committee on Heritable Disorders in Newborns and Children
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Request for nominations.
-----------------------------------------------------------------------
SUMMARY: HRSA is seeking nominations of qualified candidates to be
considered for appointment as members of the Advisory Committee on
Heritable Disorders in Newborns and Children (Committee). The Committee
provides advice, recommendations, and technical information about
aspects of heritable disorders and newborn and childhood screening to
the Secretary of HHS. HRSA is seeking nominations of qualified
candidates to fill up to three positions on the Committee.
DATE: Written nominations for membership on the Committee must be
received on or before April 30, 2018.
ADDRESSES: Nomination packages must be submitted electronically as
email attachments to Alaina Harris, Genetic Services Branch, Maternal
and Child Health Bureau (MCHB), HRSA, [email protected].
FOR FURTHER INFORMATION CONTACT: Alaina Harris. Address: MCHB, HRSA,
5600 Fishers Lane, Room 18W66, Rockville, MD 20857; phone number: (301)
443-0721; email: [email protected]. A copy of the Committee Charter and
list of the current membership can be obtained by accessing the
Committee website at www.hrsa.gov/advisory-committees/heritable-disorders.
SUPPLEMENTARY INFORMATION: The Committee was established in 2003 to
advise the Secretary of HHS regarding newborn screening tests,
technologies, policies, guidelines, and programs for
[[Page 14867]]
effectively reducing morbidity and mortality in newborns and children
having or at risk for heritable disorders. In addition, the Committee
provides advice and recommendations to the Secretary concerning the
grants and projects authorized under section 1109 of the PHSA and
technical information to develop policies and priorities for grants,
including those that will enhance the ability of the state and local
health agencies to provide for newborn and child screening, counseling
and health care services for newborns, and children having or at risk
for heritable disorders.
The Committee reviews and reports regularly on newborn and
childhood screening practices for heritable disorders, recommends
improvements in the national newborn and childhood heritable screening
programs, and recommends conditions for inclusion in the Recommended
Uniform Screening Panel (RUSP). The Committee's recommendations
regarding additional conditions/inherited disorders for screening that
have been adopted by the Secretary are included in the RUSP and
constitute part of the comprehensive guidelines supported by HRSA
pursuant to section 2713 of the PHSA, codified at 42 U.S.C. 300gg-13.
Under this provision, non-grandfathered health plans and group and
individual health insurance issuers are required to cover screenings
included in the HRSA-supported comprehensive guidelines without
charging a co-payment, co-insurance, or deductible for plan years
(i.e., in the individual market, policy years) beginning on or after
the date that is one (1) year from the Secretary's adoption of the
condition for screening.
Nominations: HRSA is requesting nominations to fill up to three (3)
positions for voting members to serve on the Committee. The Secretary
appoints committee members with the expertise needed to fulfill the
duties of the Committee established under section 1111(b) of the PHSA,
as amended by the Newborn Screening Saves Lives Reauthorization Act of
2014 (Act; 42 U.S.C. 300b-10(b)). Areas of expertise include medical,
technical, or scientific professionals with special expertise in the
field of heritable disorders or in providing screening, counseling,
testing, or specialty services for newborns and children with, or at
risk for having, heritable disorders; and/or who have expertise in
ethics (e.g., bioethics) and infectious diseases and who have worked
and published material in the area of newborn screening; and/or are
members of the public having special expertise about or concern with
heritable disorders; and/or representatives from such federal agencies,
public health constituencies, and medical professional societies.
Interested applicants may self-nominate or be nominated by another
individual or organization. Nominees must reside in the United States.
Individuals selected for appointment to the Committee will be
invited to serve for up to four (4) years. Members who are not federal
officers or permanent federal employees are appointed as special
government employees and receive a stipend and reimbursement for per
diem and travel expenses incurred for attending Committee meetings and/
or conducting other business on behalf of the Committee, as authorized
by section 5 U.S.C. 5703 for persons employed intermittently in
government service. Members who are officers or employees of the United
States Government shall not receive additional compensation for service
on the Committee, but receive per diem and travel expenses incurred for
attending Committee meetings and/or conducting other business on behalf
of the Committee.
The following information must be included in the package of
materials submitted for each individual being nominated for
consideration: (1) A statement that includes the name and affiliation
of the nominee and a clear statement regarding the basis for the
nomination, including the area(s) of expertise that may qualify a
nominee for service on the Committee, as described above; (2)
confirmation the nominee is willing to serve as a member of the
Committee; (3) the nominee's contact information (include home address,
work address, daytime telephone number, and an email address); and (4)
a current copy of the nominee's curriculum vitae. Nomination packages
may be submitted directly by the individual being nominated or by the
person/organization recommending the candidate.
HHS will endeavor to ensure that the membership of the Committee is
fairly balanced in terms of points of view represented and that
individuals from a broad representation of geographic areas, gender,
ethnic and minority groups, as well as individuals with disabilities,
are considered for membership. Appointments shall be made without
discrimination on the basis of age, ethnicity, gender, sexual
orientation, and cultural, religious, or socioeconomic status.
Individuals who are selected to be considered for appointment will
be required to provide detailed information regarding their financial
holdings, consultancies, and research grants or contracts. Disclosure
of this information is necessary in order to determine if the selected
candidate is involved in any activity that may pose a potential
conflict with the official duties to be performed as a member of the
Committee.
Authority: Section 1111 of the Public Health Service Act (PHSA),
as amended by the Newborn Screening Saves Lives Reauthorization Act
of 2014 (42 U.S.C. 300b-10). The Committee is governed by the
Federal Advisory Committee Act (FACA), as amended (5 U.S.C. App.),
and 41 CFR part 102-3, which set forth standards for the formation
and use of advisory committees.
Dated: March 30, 2018.
Lori A. Roche,
Acting Deputy Director, Division of the Executive Secretariat.
[FR Doc. 2018-07005 Filed 4-5-18; 8:45 am]
BILLING CODE 4165-15-P
