[Federal Register Volume 63, Number 180 (Thursday, September 17, 1998)]
[Notices]
[Pages 49702-49703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24911]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Partners for the National Organ and Tissue Donation Initiative

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice of opportunity for partnerships.

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SUMMARY: The Health Resources and Services Administration (HRSA), 
Department of Health and Human Services (DHHS), announces the 
opportunity for public or private nonprofit or for-profit organizations 
or corporations to develop partnerships with DHHS to carry out specific 
components of the National Organ and Tissue Donation Initiative.

DATES: To receive consideration, requests to participate as a partner 
must be received by D.W. Chen, M.D., M.P.H., Acting Director, Division 
of Transplantation, Office of Special Programs (OSP), HRSA. There are 
no deadlines applicable to this partnership opportunity.

FOR FURTHER INFORMATION CONTACT: Dr. D.W. Chen, Acting Director, 
Division of Transplantation, OSP, HRSA, Parklawn Building, Room 7-29, 
5600 Fishers Lane, Rockville, Maryland, 20857, (301) 443-7577.

SUPPLEMENTARY INFORMATION:

Background

    While medical advances now enable more than 20,000 Americans per 
year to receive organ transplants that save or enhance their lives, not 
enough organs are available to help everyone in need. As a result, 
about 4,000 people die in the U.S. each year--about 10 every day--while 
waiting for a donated kidney, liver, heart, lung, or other organ. 
Today, more than 56,000 people are on the national organ transplant 
waiting list, yet fewer than 9,000 people became organ donors in 1997. 
Two major impediments to donation are that many families of potential 
donors are not asked about donation possibilities, and many who are 
asked refuse.
    As part of DHHS' efforts to increase organ and tissue donation, 
DHHS has developed the National Organ and Tissue Donation Initiative 
(Initiative) to implement strategies for surmounting current barriers 
to donation. The goals of the Initiative are to: (1) increase consent 
to donation, (2) ensure that families of potential donors are given the 
option of donation, and (3) focus research and increase knowledge about 
what works to increase donation.
    To address these goals, DHHS will create a broad national 
partnership of public, private, and volunteer organizations to 
encourage Americans to agree to organ and tissue donation. The 
partnerships will emphasize the need to make decisions about donation 
and to share these decisions with one's family, targeting the general 
public as well as minority populations.
    The Initiative also will address health care providers, consumers, 
and physicians so that all potential donors are referred by hospitals 
to organ procurement organizations (OPOs) and families may have the 
option to donate or not to donate.
    Finally, the Initiative encourages research and evaluation to 
identify effective strategies for increasing donation. This Initiative 
will build on more than a decade of experience gained from government, 
private, and volunteer efforts.

Requirements for Partnership

    The Initiative is seeking partnerships with public or private 
nonprofit or for-profit organizations or corporations to develop and 
implement strategies addressing the goals and incorporating the 
messages of this Initiative with the overall aim of increasing organ 
and tissue donation and focusing on relevant target groups, including 
minorities, health care professionals, government agencies, community 
organizations, businesses, the general public and others. DHHS will 
reserve the right to determine the form, content, and methods utilized 
in strategies proposed by prospective partners. The Initiative 
envisions partnerships with a wide variety of groups and corporations 
that can reach the American public with the Initiative's message and 
help to increase the number of Americans willing to be organ and tissue 
donors. These partners would assist in the development and 
implementation of programs and the development and dissemination of 
information materials. Evaluation of partnership efforts is highly 
recommended. Partners' duties will include:
    (1) Identification of strategies to increase organ and tissue 
donation and, where appropriate, evaluation protocols for measuring the 
impact of these strategies; and
    (2) Implementation of identified strategies with evaluation 
procedures, where appropriate.
    Specific partnerships may be dependent on the availability of 
resources to perform the partnership activities. Partners may 
collaborate with other partners as one way to leverage and maximize 
resources.

Eligibility for Partnership

    To be eligible, an interested party must be: (1) a public or a 
private nonprofit or for-profit organization or corporation, and (2) an 
entity that, by virtue of its nature and purpose, has a legitimate 
interest in the Nation's health.

Expressions of Interest

    Each request for partnership should be in writing and contain 
information pertinent to the partnership opportunity.

Evaluation Criteria

    The partners will be selected by the Division of Organ 
Transplantation, HRSA, in consultation with the Office of the 
Secretary, DHHS, based on the following evaluation criteria:
    (1) The interested party's qualifications and capability to 
develop, implement, and (where appropriate) evaluate strategies to 
increase organ and tissue donation that are congruent with the goals 
and messages of this Initiative;
    (2) The ability of the interested party to provide or acquire 
resources for the development, implementation, and evaluation (as 
appropriate) of the proposed strategy and the interested party's 
capability of reaching the specific population(s) targeted by the 
strategy;
    (3) A description of the interested party's dealings with DHHS.

[[Page 49703]]

    In addition, the Government will evaluate carefully whether to 
enter into a partnership with an entity that would be deemed a 
``prohibited source'' under the Standards of Ethical Conduct for 
Employees of the Executive Branch, and may choose to deny a partnership 
with a ``prohibited source.'' A prohibited source has been defined in 5 
CFR 2635.203(d) as any person or entity that (1) is seeking official 
action by the agency planning the event, (2) does business or seeks to 
do business with that agency, (3) conducts activities regulated by that 
agency, (4) has interests that may be substantially affected by the 
performance or nonperformance of the official duties of an employee of 
that agency; or (5) is an organization the majority of whose members 
are described in (1)-(4) above. While partnerships with ``prohibited 
sources'' are not necessarily prohibited, the Government must weigh the 
importance of working with a given ``prohibited source'' against the 
appearance of a conflict of interest before that source may be accepted 
as a partner.
    Neither this notice nor actions pursuant thereto create a property 
right or right of any kind in any natural or artificial person 
requesting partnership. DHHS has the unilateral right to refuse to 
enter into a partnership arrangement with any entity, and the exercise 
of this right is solely within the discretion of DHHS.

Other Information

    Prior to the selection of the partners, DHHS staff involved in the 
Initiative will meet separately with those interested parties who best 
meet the evaluation criteria. In those situations where the Food and 
Drug Administration regulates the labeling of products manufactured by 
the partners, the inclusion of Initiative information on such products 
will be subject to FDA review and may require agency authorization, 
depending on how and the context in which the information is to be 
used. Further, as a general rule, restrictions will apply to the use of 
Initiative indicia so as to avoid suggestions that DHHS, or any other 
department or agency of the Federal Government, endorses any of the 
products involved in the Initiative. Once details of the program have 
been mutually agreed upon, partners will be required to enter into a 
partnership agreement with DHHS setting forth the rights and 
responsibilities of the partner and DHHS.

    Dated: September 11, 1998.
Claude Earl Fox,
Administrator.
[FR Doc. 98-24911 Filed 9-16-98; 8:45 am]
BILLING CODE 4160-15-P