[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Notices]
[Pages 11491-11492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4627]
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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 to fill expected vacancies on the Advisory
Council on Blood Stem Cell Transplantation.
The Advisory Council on Blood Stem Cell Transplantation 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 Council was chartered on
December 19, 2006.
DATES: The agency must receive nominations on or before April 1, 2011.
ADDRESSES: Nominations should be submitted to the Executive Secretary,
Advisory Council on Blood Stem Cell Transplantation, Healthcare Systems
Bureau, HRSA, Parklawn Building, Room 12C-06, 5600 Fishers Lane,
Rockville, Maryland 20857. Federal Express, Airborne, UPS, or mail
delivery should be addressed to Executive Secretary, Advisory Council
on Blood Stem Cell Transplantation, Healthcare Systems Bureau, HRSA, at
the above address. Nominations submitted electronically should be e-
mailed to [email protected].
FOR FURTHER INFORMATION CONTACT: Patricia A. Stroup, M.B.A., M.P.A.,
Executive Secretary, Advisory Council on Blood Stem Cell
Transplantation, at (301) 443-1127 or e-mail [email protected] or Robert
Baitty, Director, Blood Stem Cell Transplantation Program, Division of
Transplantation, at (301) 443-2612 or e-mail [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 Advisory Council 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 Council 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
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Council 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 including 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 Advisory Council also shall make recommendations
regarding research on emerging therapies using cells from bone marrow
and cord blood.
The Council consists of up to 25 members, including the Chair.
Members of the Advisory Council 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 Advisory Council 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
Advisory Council 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 the Division of Transplantation
of the Health Resources and Services Administration, 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 Advisory Council on Blood Stem Cell Transplantation 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 January 1, 2012.
HHS will consider nominations of all qualified individuals to
ensure that the Advisory Council 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 Advisory
Council. Nominations shall state that the nominee is willing to serve
as a member of the Council. Potential candidates will be asked to
provide detailed information concerning financial interests,
consultancies, research grants, and/or contracts that might be affected
by recommendations of the Council 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, e-mail
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, e-mail address,
and daytime telephone number at which the nominator can be contacted.
The Department 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 and, therefore, the Department encourages nominations of
qualified candidates from these groups. The Department also encourages
geographic diversity in the composition of the committee. Appointment
to this Council shall be made without discrimination on the basis of
age, race, ethnicity, gender, sexual orientation, disability, and
cultural, religious, or socioeconomic status.
Dated: February 24, 2011.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2011-4627 Filed 3-1-11; 8:45 am]
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