E8-31219. Advisory Committee on Organ Transplantation; Request for Nominations for Voting Members

AGENCY:

Health Resources and Services Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the Advisory Committee on Organ Transplantation (ACOT). The ACOT was established by the Amended Final Rule of the Organ Procurement and Transplantation Network (OPTN) (42 CFR Part 121) and, in accordance with Public Law 92-463, was chartered on September 1, 2000.

DATES:

The agency must receive nominations on or before February 2, 2009.

ADDRESSES:

All nominations should be submitted to the Executive Secretary, Advisory Committee on Organ Transplantation, Healthcare Systems Bureau, HRSA, Parklawn Building, Room 12-105, 5600 Fishers Lane, Rockville, Maryland 20857. Federal Express, Airborne, UPS, etc., mail delivery should be addressed to Executive Secretary, Advisory Committee on Organ Transplantation, Healthcare Systems Bureau, HRSA, at the above address.

FOR FURTHER INFORMATION CONTACT:

Remy Aronoff, Executive Secretary, Advisory Committee on Organ Transplantation, at [phone] or e-mail [e-mail].

SUPPLEMENTARY INFORMATION:

As provided by 42 CFR 121.12 (64 FR 56661), the Secretary established the Advisory Committee on Organ Transplantation. The Committee is governed by the Federal Advisory Committee Act (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees.

The ACOT advises the Secretary, acting through the Administrator, HRSA, on all aspects of organ procurement, allocation, and transplantation, and on other such matters that the Secretary determines. One of its principal functions is to advise the Secretary on ways to maximize Federal efforts to increase living and deceased organ donation nationally. Other matters that recently have been reviewed by the ACOT include:

• Accreditation of all establishments required to be registered with the FDA as manufacturers of human cells, tissues, and cellular- and tissue-based products;
• Concerns about U.S. citizens traveling abroad in order to receive organ transplants (also known as transplant tourism);
• Collection of data on the long-term health status of living donors;
• Organ Procurement and Transplantation Network development and distribution within the transplant community of a set of practice guidelines to be followed with respect to public solicitation of organ donors, both living and deceased; and
• Standards of coverage for living donors relating to future adverse events.

The ACOT consists of up to 25 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. In addition, the Director, Centers for Disease Control and Prevention; the Administrator, Centers for Medicare and Medicaid Services; the Commissioner, Food and Drug Administration; the Director, National Institutes of Health; and the Director, Agency for Healthcare Research and Quality (or the designees of such officials) serve as non-voting ex-officio members.

Specifically, HRSA is requesting nominations for voting members of the ACOT representing: Health care public policy; transplantation medicine and surgery, including pediatric and heart/lung transplantation; critical care medicine; nursing; epidemiology and applied statistics; immunology; law and bioethics; behavioral sciences; economics and econometrics; organ procurement organizations; transplant candidates/recipients; transplant/donor family members; and living donors. Nominees will be invited to serve a 4-year term beginning after July 2009.

HHS will consider nominations of all qualified individuals with a view to ensuring that the Advisory Committee 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 ACOT. Nominations shall state that the nominee is willing to serve as a member of the ACOT and appears to have no conflict of interest that would preclude the ACOT membership. 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 Committee to permit evaluation of possible sources of conflicts of interest.

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, 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 and a copy of his/her curriculum vitae; and (3) the name, return address, and daytime telephone number at which the nominator can be contacted.

The Department of Health and Human Services has special interest in assuring that women, minority groups, and the physically disabled are adequately represented on advisory committees; and therefore, extends particular encouragement to nominations for appropriately qualified female, minority, or disabled candidates.

Dated: December 21, 2008.

Elizabeth M. Duke,

Administrator, HRSA.