[Federal Register Volume 66, Number 192 (Wednesday, October 3, 2001)]
[Notices]
[Pages 50441-50442]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-24638]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Amendment to the Charter of the Advisory Committee on Organ 
Transplantation

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

ACTION: Notice of amendment to the Charter of the Advisory Committee on 
Organ Transplantation.

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SUMMARY: The Acting Administrator, HRSA, announces an amendment to the 
Charter of the Advisory Committee on Organ Transplantation (ACOT) to 
expand the scope of its responsibilities and increase the size of its 
membership. In addition to its current responsibilities, the Committee 
has been charged with advising the Secretary on ways to improve Federal 
and other efforts to increase organ donation nationally. The number of 
allowable Committee members has been increased from 20 to 41. Further, 
it has been specified that the term of service of the Committee 
Chairperson shall be 1 year; new member terms have been restricted to 
2, 3 and 4 years; management and support services have been transferred 
to the Office of SpecialPrograms, HRSA; and meeting frequency has been 
specified as approximately 3 times per year. Revised annual cost 
estimates have been provided.

ADDRESSES: Questions concerning this action may be addressed to Jack 
Kress, Executive Director, Advisory Committee on Organ Transplantation, 
Office of Special Programs, Health Resources and Services 
Administration, 5600 Fishers Lane, Room 7-100, Rockville, MD 20857. A 
request for a copy of the Charter, as amended, for the Advisory 
Committee on Organ Transplantation should be submitted to Miguel Kamat, 
M.D., M.P.H., Division of Transplantation, Health Resources and 
Services Administration, 5600 Fishers Lane, Room 7C-22, Rockville, MD 
20857, or may be viewed on the Division's Web site at www.hrsa.gov/osp/
dot.

FOR FURTHER INFORMATION, CONTACT: Jack Kress, (301) 443-8653.

SUPPLEMENTARY INFORMATION:   
    On September 28, 2000, HRSA published a Federal Register Notice 
regarding establishment of the ACOT pursuant to 42 CFR 121.12 and 
Public Law 92-463, the Federal Advisory Committee Act, as amended (5 
U.S.C. Appendix 2) (65 FR 58279). The unamended Charter included 
sections on the purpose, authority, function, structure, meetings, 
compensation, annual cost estimates, reports and termination dates of 
the Committee. The expanded scope of responsibilities and increased 
membership of the ACOT will ensure that the Secretary will receive 
advice on all aspects of organ donation, procurement, allocation, and 
transplantation. The Amendment specifies that, as one of its principal 
functions, the Committee shall advise the Secretary on ways to maximize 
Federal efforts to increase living and cadaveric organ donation 
nationally. The additional members will provide expert input to the 
deliberations of the ACOT when it considers questions on organ 
donation, including issues on living donation. The Committee will 
advise the Secretary through the Administrator, HRSA, on all the above 
issues, as well as on other matters that the Secretary may seek 
recommendation.
    The Charter, as amended, is reprinted below.

Advisory Committee on Organ Transplantation Charter, as Amended

Purpose

    The Department of Health and Human Services (HHS) has a vital role 
in safeguarding and promoting public health by overseeing the 
development of an equitable and effective organ donation, procurement, 
allocation, and transplantation system in the United States. The 
recommendations of the Advisory Committee on Organ Transplantation will 
facilitate HHS efforts to oversee the Organ Procurement and 
Transplantation Network (OPTN), as envisioned in the National Organ 
Transplant Act of 1984, as amended.

Authority

    42 U.S.C. 217a; Sec. 222 of the PHS Act, as amended; 42 CFR 121.12 
(64 FR 56661). The Committee is governed by the provisions of Public 
Law 92-463, as amended (5 U.S.C. Appendix 2), which sets forth 
standards for the formation and use of advisory committees.

Function

    The Committee shall advise the Secretary, acting through the 
Administrator, Health Resources and Services Administration (HRSA), on 
all aspects of organ donation, procurement, allocation, and 
transplantation, and on such other matters that the Secretary 
determines. One of its principal functions shall be to advise the 
Secretary on ways to maximize Federal efforts to increase living and 
cadaveric organ donation nationally.
    The Committee shall, at the request of the Secretary, review 
significant proposed OPTN policies submitted for Secretarial approval 
to recommend whether they should be made enforceable. It shall provide 
expert input to the Secretary on the latest advances in the science of 
transplantation, the OPTN's system of collecting, disseminating and 
ensuring the validity, accuracy, timeliness and usefulness of data, and 
additional medical, public health, ethical, legal, financial coverage, 
and socioeconomic issues that are relevant to transplantation.

Structure

    The Committee shall consist of up to 41 members, including the 
Chair. Members and Chair shall be selected by the Secretary from 
individuals knowledgeable in such fields as 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, 
economics and statistics, as well as representatives of transplant 
candidates, transplant recipients, organ donors, and family members. To 
the extent practicable, Committee members should represent the 
minority, gender and geographic diversity of transplant candidates, 
transplant recipients, organ donors and family members served by the 
OPTN. The Secretary may appoint non-voting Ex-Officio members, or 
designees of such officials, as the

[[Page 50442]]

Secretary deems necessary for the Committee to effectively carry out 
its function.
    As necessary, standing and ad hoc subcommittees, composed of 
members of the parent committee, may be established to perform specific 
functions within the Committee'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 overlapping 4-year terms, 
except that initially the Secretary shall appoint a portion of the 
members to terms of 2 years, and 3 years. Terms past the termination 
date of the Committee are contingent upon renewal of the Committee by 
appropriate action prior to this date. Members may serve after the 
expiration of their terms until their successors have taken office. The 
Secretary shall appoint a Chair from among the Committee members to 
serve for a term of 1 year, and may invite the Chair to serve 
additional term(s).
    A vacancy on the Advisory Committee 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 
Committee.
    Management and support services shall be provided by the Office of 
Special Programs, Health Resources and Services Administration.

Meetings

    Meetings shall be held approximately 3 times per year at the call 
of the Chair with the advance approval of a Government official, who 
shall also approve the agenda. A Government official shall be present 
at all meetings.
    A majority of the Committee shall constitute a quorum.
    Meetings shall be open to the public except as determined otherwise 
by the Secretary or other officials to whom the authority has been 
delegated. Notice of all meetings shall be provided to the public.
    Meetings shall be conducted, and records of the proceedings kept, 
as required by applicable laws and Departmental regulations.

Compensation

    Members shall be paid at a rate not to exceed the daily equivalent 
of the rate in effect for Executive Level IV of the Executive Schedule, 
for each day they are engaged in the performance of their duties as 
members of the Committee. Members shall receive per diem and travel 
expenses as authorized by 5 U.S.C. 5703, Title 5 U.S.C., as amended, 
for persons employed intermittently in the Government service. Members 
who are officers or employees of the United States shall not receive 
compensation for service on the Committee.

Annual Cost Estimate

    Estimated annual cost for operating the Committee, including 
compensation and travel expenses for members but excluding staff 
support, is $281,144. Estimated annual person-years of staff support 
required is 2.45, at an estimated annual cost of $218,425.

Reports

    In the event a portion of a meeting is closed to the public, a 
report shall be prepared that shall contain, at a minimum, a list of 
members and their business addresses, the Committee's function, dates 
and places of meetings, and a summary of Committee activities and 
recommendations made during the fiscal year. A copy of the report shall 
be provided to the Department Committee Management Officer.

Termination Date

    Unless renewed by appropriate action prior to its expiration, the 
Advisory Committee on Organ Transplantation shall terminate two years 
from the date this charter is approved.

    Dated: September 27, 2001.
Elizabeth M. Duke,
Acting Administrator.
[FR Doc. 01-24638 Filed 10-2-01; 8:45 am]
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