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)

Page Range		3440-3441
FR Document		2016-01127

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 Issue 13 (Thursday, January 21, 2016)

[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]]

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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 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

Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices 3441

permit evaluation of possible sources of Public Law 92–463, was chartered on The ex-officio, non-voting members
conflicts of interest. In addition, September 1, 2000. shall include the Directors of the
nominees will be asked to provide DATES: The agency must receive National Institutes of Health, the
detailed information concerning any nominations on a continuous basis. Centers for Disease Control and
employment, governance, or financial ADDRESSES: All nominations should be Prevention, and the Agency for
affiliation with any donor centers, submitted to the Executive Secretary, Healthcare Research and Quality; the
recruitment organizations, transplant ACOT, Healthcare Systems Bureau, Administrator of the Centers for
centers, and/or cord blood banks. HRSA, 5600 Fishers Lane, Room Medicare & Medicaid Services; the
A nomination package should be sent 08N182, Rockville, Maryland 20857. Commissioner of the Food and Drug
in as hard copy, email communication, Federal Express, Airborne, UPS, etc., Administration; and the Chair, Advisory
or on compact disc. A nomination mail delivery should be addressed to Committee on Blood and Tissue and
package should include the following Executive Secretary, Advisory Safety Availability—or their designees.
information for each nominee: (1) A Committee on Organ Transplantation, Specifically, HRSA is requesting
letter of nomination stating the name, Healthcare Systems Bureau, HRSA, at nominations for voting members of the
affiliation, and contact information for the above address, or via email to: ACOT representing: Health care public
the nominee, the basis for the PStroup@hrsa.gov and PTongele@ policy; transplantation medicine and
nomination (i.e., what specific attributes hrsa.gov. surgery, including pediatric and heart/
recommend him/her for service in this lung transplantation; critical care
FOR FURTHER INFORMATION CONTACT: medicine; nursing; epidemiology and
capacity), and the nominee’s field(s) of
Patricia A. Stroup, M.B.A., M.P.A., applied statistics; immunology; law and
expertise; (2) a biographical sketch of
Executive Secretary, ACOT, at (301) bioethics; behavioral sciences;
the nominee and a copy of his/her
443–1127 or email PStroup@hrsa.gov. economics and econometrics; organ
curriculum vitae; and (3) the name,
SUPPLEMENTARY INFORMATION: As procurement organizations; transplant
return address, email address, and
daytime telephone number at which the provided by 42 CFR 121.12, the candidates/recipients; transplant/donor
nominator can be contacted. Secretary established the ACOT. The family members; and living donors.
HHS strives to ensure that the ACOT is governed by the Federal Nominees will be invited to serve up to
membership of HHS federal advisory Advisory Committee Act (5 U.S.C. a 4-year term.
committees is balanced in terms of Appendix 2), which sets forth standards The Department of Health and Human
points of view represented, consistent for the formation and use of advisory Services (HHS) will consider
with the committee’s authorizing statute committees. nominations of all qualified individuals
The ACOT advises the Secretary on with a view to ensuring that the ACOT
and charter. Appointment to the
all aspects of organ procurement, includes the areas of subject matter
ACBSCT shall be made without
allocation, and transplantation, and on expertise noted above. Individuals may
discrimination on the basis of age, race,
other such matters that the Secretary nominate themselves or other
ethnicity, gender, sexual orientation,
determines. One of its principal individuals, and professional
disability, and cultural, religious, or
functions is to advise the Secretary on associations and organizations may
socioeconomic status. The Department
federal efforts to maximize the number nominate one or more qualified persons
encourages nominations of qualified
of deceased donor organs made for membership on the ACOT.
candidates from all groups and
available for transplantation and to Nominations shall state that the
locations.
support the safety of living organ nominee is willing to serve as a member
Jackie Painter, donation. of the ACOT and appears to have no
Director, Division of the Executive Secretariat. The ACOT consists of up to 25 conflict of interest that would preclude
[FR Doc. 2016–01127 Filed 1–20–16; 8:45 am] members, who are Special Government the ACOT membership. Potential
BILLING CODE 4165–15–P
Employees, and 6 ex-officio, non-voting candidates will be asked to provide
members. Members and the Chair shall detailed information concerning
be appointed by the Secretary from financial interests, consultancies,
DEPARTMENT OF HEALTH AND individuals knowledgeable in such research grants, and/or contracts that
HUMAN SERVICES fields as deceased and living organ might be affected by recommendations
donation, health care public policy, of the ACOT to permit evaluation of
Health Resources and Services transplantation medicine and surgery, possible sources of conflicts of interest.
Administration critical care medicine and other medical A nomination package should include
specialties involved in the identification the following information for each
Advisory Committee on Organ and referral of donors, non-physician nominee:
TransplantationRequest for transplant professions, nursing, (1) A letter of nomination stating the
Nominations for Voting Members epidemiology, immunology, law and name, affiliation, and contact
AGENCY: Health Resources and Services bioethics, behavioral sciences, information for the nominee, the basis
Administration, HHS. economics and statistics, as well as for the nomination (i.e., what specific
ACTION: Notice of request for representatives of transplant candidates, attributes, perspectives, and/or skills
nominations. transplant recipients, living organ does the individual possess that would
donors, and family members of benefit the workings of ACOT), and the
SUMMARY: The Health Resources and deceased and living organ donors. nominee’s field(s) of expertise; (2) a
asabaliauskas on DSK9F6TC42PROD with NOTICES

Services Administration (HRSA) is Members shall not serve while they are biographical sketch of the nominee and
requesting nominations to fill vacancies also serving on the OPTN Board of a copy of his/her curriculum vitae; and
on the Advisory Committee on Organ Directors. To the extent practicable, (3) the name, address, daytime
Transplantation (ACOT). The ACOT Committee members should represent telephone number, and email address at
was established by the Amended Final minority, gender and geographic which the nominator can be contacted.
Rule of the Organ Procurement and diversity of transplant candidates, HHS strives to ensure that the
Transplantation Network (OPTN) (42 transplant recipients, organ donors and membership of HHS federal advisory
CFR part 121) and, in accordance with family members served by the OPTN. committees is balanced in terms of

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Document Created: 2018-02-02 12:33:45
Document Modified: 2018-02-02 12:33:45

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		The agency will receive nominations on a continuous basis.
Contact		Patricia A. Stroup, M.B.A., M.P.A., Executive Secretary, ACBSCT, at (301) 443-1127 or email [email protected]
FR Citation		81 FR 3440

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

DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth Resources and Services Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration