[Federal Register Volume 72, Number 14 (Tuesday, January 23, 2007)]
[Notices]
[Pages 2892-2893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-891]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Establishment of Advisory Council on Blood Stem Cell 
Transplantation and Solicitation of Nominations for Membership

AGENCY: Health Resources and Services Administration (HRSA), HHS.

ACTION: Notice of establishment of the Advisory Council on Blood Stem 
Cell Transplantation and Solicitation of Nominations for Membership.

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SUMMARY: Pursuant to Public Law 109-129, 42 U.S.C. 274k (section 379 of 
the Public Health Service Act, as amended) and the Federal Advisory 
Committee Act, as amended (5 U.S.C. Appendix 2), the Administrator, 
HRSA, announces the establishment of the Advisory Council on Blood Stem 
Cell Transplantation by the Secretary, HHS. The Council will advise the 
Secretary on proposed C.W. Bill Young Cell Transplantation Program 
policies and other such matters as the Secretary determines.
    Duration of this Council is for two years unless renewed by the 
Secretary, HHS. This notice also requests nominations for membership on 
the Council.

DATES: Nominations for members must be received on or before February 
22, 2007.

ADDRESSES: All 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, or 
UPS, mail delivery should be addressed to Executive Secretary, Advisory 
Council on Blood Stem Cell Transplantation, Healthcare Systems Bureau, 
HRSA, at the above address.

FOR FURTHER INFORMATION CONTACT: Remy Aronoff, Executive Secretary, 
Advisory Council on Blood Stem Cell Transplantation, at (301) 443-3264 
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:

I. Background and Authority

    Establishment of the Council implements 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 (5 U.S.C. 
Appendix 2), which sets forth standards for the formation and use of 
advisory committees.
    The Advisory Council shall advise 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 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.

II. Structure

    The Council shall consist 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.
    The Council also shall include as nonvoting members 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 and the National Institutes of Health. The 
Secretary may also appoint other non-voting ex officio members, or 
designees of such officials, as the Secretary deems necessary for the 
Council to effectively carry out its functions.
    As necessary, subcommittees composed of members of the parent 
Council, may be established with the approval of the Secretary of HHS 
or his designee to perform specific functions within the Council's 
jurisdiction. The Department Committee Management Officer shall be 
notified upon establishment of each subcommittee, and shall be provided 
information on its name, membership, function, and estimated frequency 
of meetings.
    Members shall be invited to serve for a term of 2 years, and 
(assuming the Council's term is extended) each such member may serve as 
many as 3 consecutive 2-year terms, except that such limitations shall 
not apply to the

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Chair of the Council (or the Chair-elect) or to the member of the 
Council who most recently served as the Chair; and one additional 
consecutive 2-year term may be served by any member of the Council who 
has no employment, governance, or financial affiliation with any donor 
center, recruitment organization, transplant center, or cord blood 
bank. A member of the Council may continue to serve after the 
expiration of the term of such member until a successor is appointed. 
In order to ensure the continuity of the Council, the Council shall be 
appointed so that each year the terms of approximately one-third of the 
members of the Council expires. Any member of the Council who has an 
employment, governance, or financial affiliation with a donor center, 
recruitment organization, transplant center, or cord blood bank will be 
prohibited from participating in any decision that materially affects 
the donor center, recruitment organization, transplant center, or cord 
blood bank. The number of members with such affiliations on the Council 
shall be limited. Meetings shall be held up to 3 times per year at the 
call of the Designated Federal Official or designee who shall approve 
the agenda and shall be present at all meetings.
    A vacancy on the Council shall be filled in the manner in which the 
original appointment was made and shall be subjected to any conditions 
that applied with respect to the original appointment. An individual 
chosen to fill a vacancy shall be appointed for the remainder of the 
term of the member replaced. The vacancy shall not affect the power of 
the remaining members to execute the duties of the Council.
    All members of HRSA advisory committees shall adhere to the 
conflict of interest rules applicable to Special Government Employees 
as such employees are defined in 18 U.S.C. section 202(a). These rules 
include relevant provisions in 18 U.S.C. related to criminal activity, 
Standards of Ethical Conduct for Employees of the Executive Branch (5 
CFR part 2635), and Executive Order 12674 (as modified by Executive 
Order 12731).
    Management and support services shall be provided by the Director, 
Division of Transplantation, Healthcare Systems Bureau, HRSA.

III. Compensation

    Members shall be paid at a rate of $200 for each day they are 
engaged in the performance of their duties as members of the Council. 
Members shall receive per diem and travel expenses as authorized by 5 
U.S.C. 5703, as amended, for persons employed intermittently in the 
Government service. Members who are officers or employees of the United 
States Government shall not receive compensation for service on the 
Council.

IV. Nominations

    HHS will consider nominations of all qualified individuals to 
ensure that the Advisory Council includes the areas of subject matter 
expertise noted above (see ``Structure''). 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 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.
    HHS has special interest in assuring that women, minority groups, 
and the physically disabled are adequately represented on advisory 
committees; and therefore, extends particular encouragement to 
nominations for appropriately qualified female, minority, or disabled 
candidates. HHS also encourages geographic diversity in the composition 
of the Council.
    All nomination information should be provided in a single, complete 
package within 30 days of the publication of this notice. All 
nominations for membership should be sent to the Executive Secretary of 
the Council at the address provided above.

    Dated: January 16, 2007.
Elizabeth M. Duke,
Administrator.
[FR Doc. E7-891 Filed 1-22-07; 8:45 am]
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