Solicitation of Nominations for Membership To Serve on the Advisory Committee on Organ Transplantation, 28631-28632 [2021-11209]

Download as PDF Federal Register / Vol. 86, No. 101 / Thursday, May 27, 2021 / Notices consider it acceptable to collect certain data in the postmarket setting, rather than premarket under certain circumstances when FDA has uncertainty regarding certain benefits or risks of the device, but the degree of uncertainty is acceptable in the context of the overall benefit-risk profile of the device at the time of premarket approval. 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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 This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Procedures for Handling PostApproval Studies Imposed by Premarket Approval Application Order.’’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, E:\FR\FM\27MYN1.SGM 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/index.html. 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 E:\FR\FM\27MYN1.SGM 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]


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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