[Federal Register Volume 78, Number 170 (Tuesday, September 3, 2013)]
[Notices]
[Pages 54257-54258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21345]
[[Page 54257]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Council on Blood Stem Cell Transplantation; Request for
Nominations for Voting Members
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Notice.
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SUMMARY: The Health Resources and Services Administration (HRSA) is
requesting nominations of qualified candidates to fill expected
vacancies on the Advisory Council on Blood Stem Cell Transplantation
(ACBSCT).
The ACBSCT was established pursuant to Public Law 109-129 as
amended by Public Law 111-264; 42 U.S.C. 274k; Section 379 of the
Public Health Service Act. In accordance with Public Law 92-463, the
ACBSCT was chartered on December 19, 2006.
DATES: The agency must receive nominations on or before 30 days after
date of publication in the Federal Register.
ADDRESSES: Nominations should be submitted to the Executive Secretary,
ACBSCT, Healthcare Systems Bureau, HRSA, Parklawn Building, Room 12C-
06, 5600 Fishers Lane, Rockville, Maryland 20857. Federal Express,
Airborne, or UPS mail delivery should be addressed to Executive
Secretary, ACBSCT, Healthcare Systems Bureau, HRSA, at the above
address. Nominations submitted electronically should be emailed to
[email protected] and [email protected].
FOR FURTHER INFORMATION CONTACT: Patricia A. Stroup, M.B.A., M.P.A.,
Executive Secretary, ACBSCT, at (301) 443-1127; or email at
[email protected].
SUPPLEMENTARY INFORMATION: The Council was established to implement a
statutory requirement of the Stem Cell Therapeutic and Research Act of
2005 (Pub. L. 109-129). The Council is governed by the Federal Advisory
Committee Act, as amended (5 U.S.C. Appendix 2), which sets forth
standards for the formation and use of advisory committees.
The ACBSCT advises the Secretary and the Administrator, HRSA, on
matters related to the activities of the C.W. Bill Young Cell
Transplantation Program and the National Cord Blood Inventory Program.
The ACBSCT shall, as requested by the Secretary, discuss and make
recommendations regarding the C.W. Bill Young Cell Transplantation
Program (Program). It shall provide a consolidated, comprehensive
source of expert, unbiased analysis and recommendations to the
Secretary on the latest advances in the science of blood stem cell
transplantation. The ACBSCT shall advise, assist, consult, and make
recommendations at the request of the Secretary, on broad Program
policy in areas such as the necessary size and composition of the adult
donor pool available through the Program and the composition of the
National Cord Blood Inventory; requirements regarding informed consent
for cord blood donation; accreditation requirements for cord blood
banks; the scientific factors that define a cord blood unit as high
quality; public and professional education to encourage the ethical
recruitment of genetically diverse donors and ethical donation
practices; criteria for selecting the appropriate blood stem source for
transplantation; Program priorities; research priorities; and the scope
and design of the Stem Cell Therapeutic Outcomes Database. It also
shall, at the request of the Secretary, review and advise on issues
relating more broadly to the field of blood stem cell transplantation,
such as regulatory policy pertaining to the compatibility of
international regulations, and actions that may be taken by the state
and federal governments and public and private insurers to increase
donation and access to transplantation. The ACBSCT also shall make
recommendations regarding research on emerging therapies using cells
from bone marrow and cord blood.
The ACBSCT consists of up to 25 members, including the Chair.
Members of the ACBSCT shall be chosen to ensure objectivity and
balance, and reduce the potential for conflicts of interest. The
Secretary shall establish bylaws and procedures to prohibit any member
of the ACBSCT who has an employment, governance, or financial
affiliation with a donor center, recruitment organization, transplant
center, or cord blood bank from participating in any decision that
materially affects the center, recruitment organization, transplant
center, or cord blood bank; and to limit the number of members of the
ACBSCT with any such affiliation.
The members and chair shall be selected by the Secretary from
outstanding authorities and representatives of marrow donor centers and
marrow transplant centers; representatives of cord blood banks and
participating birthing hospitals; recipients of a bone marrow
transplant; recipients of a cord blood transplant; persons who require
such transplants; family members of such a recipient or family members
of a patient who has requested the assistance of the Program in
searching for an unrelated donor of bone marrow or cord blood; persons
with expertise in bone marrow and cord blood transplantation; persons
with expertise in typing, matching, and transplant outcome data
analysis; persons with expertise in the social sciences; basic
scientists with expertise in the biology of adult stem cells;
ethicists; hematology and transfusion medicine researchers with
expertise in adult blood stem cells; persons with expertise in cord
blood processing; and members of the general public.
In addition, representatives from HRSA's Division of
Transplantation, the Department of Defense Marrow Recruitment and
Research Program operated by the Department of the Navy, the Food and
Drug Administration, the National Institutes of Health, the Centers for
Medicare and Medicaid Services, and the Centers for Disease Control and
Prevention serve as non-voting ex officio members.
Specifically, HRSA is requesting nominations for voting members of
the ACBSCT in these categories: Marrow donor centers and transplant
center representatives; cord blood banks and participating hospitals
representatives; recipients of cord blood transplant; family members of
bone marrow transplant and cord blood transplant recipients or family
members of a patient who has requested assistance by the Program in
searching for an unrelated donor; persons with expertise in bone marrow
or cord blood transplantation; persons with expertise in typing,
matching, and transplant outcome data analysis; persons with expertise
in social sciences; basic scientists with expertise in the biology of
adult stem cells; researchers in hematology and transfusion medicine
with expertise in adult blood stem cells; persons with expertise in
cord blood processing; and members of the general public. Nominees will
be invited to serve a 2 to 6-year term beginning after July 1, 2014.
HHS will consider nominations of all individuals to ensure that the
ACBSCT includes the areas of subject matter expertise noted above.
Individuals may nominate themselves or other individuals, and
professional associations and organizations may nominate one or more
qualified persons for membership on the ACBSCT. Nominations shall state
that the nominee is willing to serve as a member of the ACBSCT.
Potential candidates
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will be asked to provide detailed information concerning financial
interests, consultancies, research grants, and/or contracts that might
be affected by recommendations of the ACBSCT to permit evaluation of
possible sources of conflicts of interest. In addition, nominees will
be asked to provide detailed information concerning any employment,
governance, or financial affiliation with any donor centers,
recruitment organizations, transplant centers, and/or cord blood banks.
A nomination package should be sent in as hard copy, email
communication, or on compact disc. 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 recommend
him/her for service in this capacity), 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, return address, email address,
and daytime telephone number at which the nominator can be contacted.
HHS strives 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 to ensure that the
views of women, all ethnic and racial groups, and people with
disabilities are represented on HHS Federal advisory committees. The
Department also encourages geographic diversity in the composition of
the committee. The Department encourages nominations of qualified
candidates from all groups and locations. Appointment to the ACBSCT
shall be made without discrimination on the basis of age, race,
ethnicity, gender, sexual orientation, disability, and cultural,
religious, or socioeconomic status.
Dated: August 26, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-21345 Filed 8-30-13; 8:45 am]
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