Solicitation of Nominations for Membership To Serve on the Advisory Committee on Organ Transplantation, 28631-28632 [2021-11209]
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Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
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[FR Doc. 2021–11216 Filed 5–26–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Solicitation of Nominations for
Membership To Serve on the Advisory
Committee on Organ Transplantation
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Request for nominations.
AGENCY:
HRSA is seeking nominations
of qualified candidates to be considered
for appointment as members of the
Advisory Committee on Organ
Transplantation (ACOT or Committee).
ACOT provides advice and
recommendations to the Secretary of
HHS (Secretary) on matters pertaining to
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Æ revised FDA review time goals for
PAS-related submissions.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Procedures for Handling PostApproval Studies Imposed by Premarket
Approval Application Order.’’ It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
21 CFR part
Dated: May 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
VerDate Sep<11>2014
17:29 May 26, 2021
Jkt 253001
28631
organ donation, procurement,
allocation, and transplantation;
maximizing the number of deceased
donor organs available for
transplantation; supporting the safety of
living organ donation proposed policies
of the Organ Procurement and
Transplantation Network (OPTN) and
OPTN operations; and the latest
advances in the science of
transplantation.
Authority: In accordance with 42 CFR
121.12, the Secretary established ACOT
pursuant to 42 U.S.C. 217a. The Committee
is governed by the Federal Advisory
Committee Act (FACA) (5 U.S.C. Appendix
2), which sets forth standards for the
formation and use of advisory committees.
Written nominations for
membership on the ACOT will be
received on a continuous basis.
ADDRESSES: Nomination packages must
be submitted to the Executive Secretary,
ACOT, Healthcare Systems Bureau,
HRSA, Room 08W67, 5600 Fishers
Lane, Rockville, Maryland 20857, or via
email to: ACOTHRSA@hrsa.gov.
FOR FURTHER INFORMATION CONTACT:
Shelley Grant, Executive Secretary,
ACOT, at (301) 443–8036 or email
DATES:
PO 00000
Frm 00107
Fmt 4703
Sfmt 4703
0910–0231
0910–0332
sgrant@hrsa.gov. A copy of the ACOT
charter and list of current members may
be obtained by accessing the ACOT
website at https://www.organdonor.gov/
about-dot/acot.html.
SUPPLEMENTARY INFORMATION: In
accordance with the Amended Final
Rule of the OPTN (42 CFR part 121), the
ACOT was established pursuant to 42
U.S.C. 217a and, in accordance with
Public Law 92–463, was first chartered
on September 1, 2000. The ACOT meets
up to three times during the fiscal year.
Nominations: HRSA is requesting
nominations for voting members to
serve as Special Government Employees
(SGEs) on ACOT. The Secretary
appoints ACOT members with the
expertise needed to fulfill the duties of
the Advisory Committee. Nominees
sought are individuals knowledgeable in
such fields as deceased and living organ
donation, health care public policy,
transplantation medicine and surgery,
critical care medicine, and other
medical specialties involved in the
identification and referral of donors,
non-physician transplant professions,
nursing, epidemiology, immunology,
law and bioethics, behavioral sciences,
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27MYN1
jbell on DSKJLSW7X2PROD with NOTICES
28632
Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices
economics, and statistics, as well as
representatives of transplant candidates,
transplant recipients, living organ
donors, and family members of
deceased and living organ donors.
Interested applicants may self-nominate
or be nominated by another individual
or organization.
Individuals selected for appointment
to the Committee will be invited to
serve for a term up to 4 years. Members
appointed as SGEs receive a stipend and
reimbursement for per diem and travel
expenses incurred for attending ACOT
meetings and/or conducting other
business on behalf of the ACOT, as
authorized by 5 U.S.C. 5703 of FACA for
persons employed intermittently in
government service.
The following information must be
included in the package of materials
submitted for each individual being
nominated for consideration: (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, perspectives, and/or skills
does the individual possess that would
benefit the workings of ACOT), and the
nominee’s field(s) of expertise; (2) a
biographical sketch of the nominee; (3)
the name, address, daytime telephone
number, and email address at which the
nominator can be contacted; and (4) a
current copy of the nominee’s
curriculum vitae. Nomination packages
may be submitted directly by the
individual being nominated or by the
person/organization recommending the
candidate.
HHS endeavors to ensure that the
membership of ACOT is fairly balanced
in terms of points of view represented
and that individuals from a broad
representation of geographic areas,
gender, and ethnic and minority groups,
as well as individuals with disabilities,
are considered for membership.
Appointments shall be made without
discrimination on the basis of age,
ethnicity, gender, sexual orientation, or
cultural, religious, or socioeconomic
status.
Individuals who are selected to be
considered for appointment will be
required to provide detailed information
regarding their financial holdings,
consultancies, and research grants or
contracts. Disclosure of this information
is required for HRSA ethics officials to
determine whether there is a conflict
between the SGE’s public duties as a
member of ACOT and their private
interests, including an appearance of a
loss of impartiality as defined by federal
laws and regulations, and to identify
VerDate Sep<11>2014
17:29 May 26, 2021
Jkt 253001
any required remedial action needed to
address the potential conflict.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–11209 Filed 5–26–21; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Solicitation of Nominations for
Membership To Serve on the Advisory
Council on Blood Stem Cell
Transplantation
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Request for nominations.
AGENCY:
HRSA is seeking nominations
of qualified candidates to be considered
for appointment as members of the
Advisory Council on Blood Stem Cell
Transplantation (ACBSCT or Council).
ACBSCT shall advise the Secretary of
HHS (Secretary), through the HRSA
Administrator, on the activities of the
C.W. Bill Young Cell Transplantation
Program and the National Cord Blood
Inventory Program (Program).
SUMMARY:
Authority: 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 (FACA), as amended (5 U.S.C. Appendix
2), which sets forth standards for the
formation and use of advisory committees.
Written nominations for
membership on ACBSCT will be
received continuously.
ADDRESSES: Nomination packages must
be submitted to the Executive Secretary,
ACBSCT, Healthcare Systems Bureau,
HRSA, Room 08W60, 5600 Fishers
Lane, Rockville, Maryland 20857, or
sent via email to: ACBSCTHRSA@
hrsa.gov.
DATES:
FOR FURTHER INFORMATION CONTACT:
Shelley Grant, Executive Secretary,
ACBSCT, at (301) 443–8036 or email
sgrant@hrsa.gov. A copy of the ACBSCT
charter and a list of current members
may be obtained by accessing the
ACBSCT website at https://
bloodcell.transplant.hrsa.gov/about/
advisory_council/.
SUPPLEMENTARY INFORMATION: 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
PO 00000
Frm 00108
Fmt 4703
Sfmt 4703
ACBSCT was chartered on December 19,
2006. ACBSCT meets up to three times
during the fiscal year.
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. ACBSCT shall advise,
assist, consult, and make
recommendations, at the request of the
Secretary, on (1) 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, (2) requirements regarding
informed consent for cord blood
donation, (3) accreditation requirements
for cord blood banks, (4) the scientific
factors that define a cord blood unit as
high quality, (5) public and professional
education to encourage the ethical
recruitment of genetically diverse
donors and ethical donation practices,
(6) criteria for selecting the appropriate
blood stem source for transplantation,
(7) program priorities; (8) research
priorities, and (9) the scope and design
of the Stem Cell Therapeutic Outcomes
Database.
At the request of the Secretary,
ACBSCT shall also 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 state and federal governments
and public and private insurers to
increase donation and access to
transplantation. ACBSCT shall also
make recommendations regarding
research on emerging therapies using
cells from bone marrow and cord blood.
The Council may meet up to three times
during the fiscal year.
Nominations: HRSA is requesting
nominations for voting members to
serve as Special Government Employees
(SGEs) on ACBSCT. The Council shall
consist of up to 25 members who are
SGEs and 6 ex-officio, non-voting
members. The Secretary appoints
ACBSCT SGEs with the expertise
needed to fulfill the duties of the
Council. HRSA is seeking nominees
who are outstanding authorities and
representatives of marrow donor centers
and marrow transplant centers;
representatives of cord blood banks and
participating birthing hospitals;
recipients of bone marrow transplants;
recipients of cord blood transplants;
persons who require such transplants;
family members of such a recipient or
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27MYN1
Agencies
[Federal Register Volume 86, Number 101 (Thursday, May 27, 2021)]
[Notices]
[Pages 28631-28632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11209]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Solicitation of Nominations for Membership To Serve on the
Advisory Committee on Organ Transplantation
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Request for nominations.
-----------------------------------------------------------------------
SUMMARY: HRSA is seeking nominations of qualified candidates to be
considered for appointment as members of the Advisory Committee on
Organ Transplantation (ACOT or Committee). ACOT provides advice and
recommendations to the Secretary of HHS (Secretary) on matters
pertaining to organ donation, procurement, allocation, and
transplantation; maximizing the number of deceased donor organs
available for transplantation; supporting the safety of living organ
donation proposed policies of the Organ Procurement and Transplantation
Network (OPTN) and OPTN operations; and the latest advances in the
science of transplantation.
Authority: In accordance with 42 CFR 121.12, the Secretary
established ACOT pursuant to 42 U.S.C. 217a. The Committee is
governed by the Federal Advisory Committee Act (FACA) (5 U.S.C.
Appendix 2), which sets forth standards for the formation and use of
advisory committees.
DATES: Written nominations for membership on the ACOT will be received
on a continuous basis.
ADDRESSES: Nomination packages must be submitted to the Executive
Secretary, ACOT, Healthcare Systems Bureau, HRSA, Room 08W67, 5600
Fishers Lane, Rockville, Maryland 20857, or via email to:
[email protected].
FOR FURTHER INFORMATION CONTACT: Shelley Grant, Executive Secretary,
ACOT, at (301) 443-8036 or email [email protected]. A copy of the ACOT
charter and list of current members may be obtained by accessing the
ACOT website at https://www.organdonor.gov/about-dot/acot.html.
SUPPLEMENTARY INFORMATION: In accordance with the Amended Final Rule of
the OPTN (42 CFR part 121), the ACOT was established pursuant to 42
U.S.C. 217a and, in accordance with Public Law 92-463, was first
chartered on September 1, 2000. The ACOT meets up to three times during
the fiscal year.
Nominations: HRSA is requesting nominations for voting members to
serve as Special Government Employees (SGEs) on ACOT. The Secretary
appoints ACOT members with the expertise needed to fulfill the duties
of the Advisory Committee. Nominees sought are individuals
knowledgeable in such fields as deceased and living organ donation,
health care public policy, transplantation medicine and surgery,
critical care medicine, and other medical specialties involved in the
identification and referral of donors, non-physician transplant
professions, nursing, epidemiology, immunology, law and bioethics,
behavioral sciences,
[[Page 28632]]
economics, and statistics, as well as representatives of transplant
candidates, transplant recipients, living organ donors, and family
members of deceased and living organ donors. Interested applicants may
self-nominate or be nominated by another individual or organization.
Individuals selected for appointment to the Committee will be
invited to serve for a term up to 4 years. Members appointed as SGEs
receive a stipend and reimbursement for per diem and travel expenses
incurred for attending ACOT meetings and/or conducting other business
on behalf of the ACOT, as authorized by 5 U.S.C. 5703 of FACA for
persons employed intermittently in government service.
The following information must be included in the package of
materials submitted for each individual being nominated for
consideration: (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, perspectives, and/or skills
does the individual possess that would benefit the workings of ACOT),
and the nominee's field(s) of expertise; (2) a biographical sketch of
the nominee; (3) the name, address, daytime telephone number, and email
address at which the nominator can be contacted; and (4) a current copy
of the nominee's curriculum vitae. Nomination packages may be submitted
directly by the individual being nominated or by the person/
organization recommending the candidate.
HHS endeavors to ensure that the membership of ACOT is fairly
balanced in terms of points of view represented and that individuals
from a broad representation of geographic areas, gender, and ethnic and
minority groups, as well as individuals with disabilities, are
considered for membership. Appointments shall be made without
discrimination on the basis of age, ethnicity, gender, sexual
orientation, or cultural, religious, or socioeconomic status.
Individuals who are selected to be considered for appointment will
be required to provide detailed information regarding their financial
holdings, consultancies, and research grants or contracts. Disclosure
of this information is required for HRSA ethics officials to determine
whether there is a conflict between the SGE's public duties as a member
of ACOT and their private interests, including an appearance of a loss
of impartiality as defined by federal laws and regulations, and to
identify any required remedial action needed to address the potential
conflict.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021-11209 Filed 5-26-21; 8:45 am]
BILLING CODE 4165-15-P