81 FR 3440 - Advisory Council on Blood Stem Cell Transplantation; Request for Nominations for Voting Members

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 81, Issue 13 (January 21, 2016)

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.

[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3440-3441]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-01127]



[[Page 3440]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 will receive nominations on a continuous basis.

ADDRESSES: Nominations should be submitted to the Executive Secretary, 
ACBSCT, Healthcare Systems Bureau, HRSA, 5600 Fishers Lane, Room 
08N182, Rockville, MD 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 
[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 (Program) and the National Cord Blood Inventory 
Program.
    The ACBSCT shall, as requested by the Secretary, discuss and make 
recommendations regarding the 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 & 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-year term, beginning the date of appointment, 
with the possibility of additional 2-year terms, not to exceed 6 years 
consecutively.
    HHS will consider nominations of all qualified 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 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

[[Page 3441]]

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 balanced in terms of points of view represented, 
consistent with the committee's authorizing statute and charter. 
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. The Department 
encourages nominations of qualified candidates from all groups and 
locations.

Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-01127 Filed 1-20-16; 8:45 am]
 BILLING CODE 4165-15-P