[Federal Register Volume 64, Number 64 (Monday, April 5, 1999)]
[Notices]
[Pages 16473-16475]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8175]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Extramural Support Program for Projects to Increase Organ and 
Tissue Donation

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice with comment period.

-----------------------------------------------------------------------

SUMMARY: The Health Resources and Services Administration (HRSA), 
Department of Health and Human Services (HHS), announces a proposed 
peer reviewed, competitively awarded extramural support program for 
fiscal year 1999 to fund projects to increase organ and tissue 
donation. This document sets forth the proposed parameters of the 
extramural support program and offers a 30-day period for public 
comment on: the project phases eligible for program support (pilot 
tests and replications), performance measures, funding priorities, and 
review criteria. Comments will be considered for the purpose of writing 
the detailed guidance to applicants for submission of applications. 
Applications will be solicited for this extramural support program by 
posting the announcement on the following three web sites: 
www.hrsa.gov, www.hrsa.gov/osp/dot/, and www.organdonor.gov, and by 
publishing it as a Federal Register notice.
    In concert with HHS'' National Organ and Tissue Donation 
Initiative, this extramural program intends, through cooperative 
agreements, to support projects of up to 3 years duration to implement, 
evaluate, and disseminate model interventions with the greatest 
potential for yielding a verifiable and demonstrable impact on donation 
and which are replicable, transferable, and feasible in practice. 
Applicants must be qualified organ procurement organizations (OPOs) or 
other nonprofit, private organizations, in collaboration with a 
consortium of other relevant entities. Strong evaluation project 
components and staffing expertise are required. Authority for this 
program is provided by Section 371(a)(3) of the Public Health Service 
(PHS) Act, 42 U.S.C. 273(a)(3), as amended.

DATES: To ensure consideration, comments must be received by May 5, 
1999.

ADDRESSES: Written comments should be addressed to: D.W. Chen, M.D., 
M.P.H., Director, Division of Transplantation, Office of Special 
Programs, Health Resources and Services Administration, U.S. Department 
of Health and Human Services, Room 4-81, Parklawn Building, 5600 
Fishers Lane, Rockville, MD 20857. All comments received will be 
available for public inspection and copying at the Division of 
Transplantation, at the above address, weekdays (Federal holidays 
excepted) between the hours of 9:00 a.m. and 5:00 p.m.

FOR FURTHER INFORMATION CONTACT: D.W. Chen, M.D., M.P.H., Director, 
Division of Transplantation, Office of Special Programs, Health 
Resources and Services Administration, U.S. Department of Health and 
Human Services, Room 4-81, Parklawn Building, 5600 Fishers Lane, 
Rockville, MD 20857; 301 443-7577.

SUPPLEMENTARY INFORMATION:

Purposes

    Organ donation has become an increasingly important public health 
issue. Only about 5,500 deaths in the United States each year result in 
organ donation, compared with an estimated potential of 8,000-15,000 
donors. Moreover, almost 62,000 patients are currently awaiting 
transplants and about 4,000 patients die each year because of the 
critical shortage of transplantable organs.
    A major barrier to donation today is low rates of family consent. 
The Health Care Financing Administration's revised Hospital Conditions 
of Participation for Organ, Tissue, and Eye Donation (June 22, 1998, 63 
Fed. Reg. 33856) effective August 21, 1998, are designed to maximize 
opportunities to donate by requiring Medicaid-and Medicare-
participating hospitals to notify OPOs of all deaths and imminent 
deaths so potential donors are identified and families are asked about 
donation; however, only about half of families who are asked give their 
consent. The latest national Gallup survey indicates that nearly all 
Americans would consent to donation if they knew that their loved one 
had requested it, but only about half of Americans who want to donate 
have told their families.
    The goals of this program are to implement, evaluate, and 
disseminate

[[Page 16474]]

model interventions with the greatest potential for yielding a 
verifiable and demonstrable impact on donation and which are 
replicable, transferable, and feasible in practice. While the program 
focuses on organ donation, it is expected that projects to increase 
organ donation will have a similar impact on tissue donation. We 
propose that program funding be used to support the following project 
phases: (1) pilot testing and (2) replication. Phase 1 projects that 
test the efficacy of promising interventions to increase organ donation 
are anticipated to be smaller in scope and budget than Phase 2 
projects, which will focus on implementing and testing in multiple 
sites interventions which already have proved effective in pilot 
studies. Phase 2 projects also can include dissemination efforts 
including such strategies as training workshops and remote and on-site 
technical assistance. Applicants must submit separate applications if 
they are interested in applying for both types of projects.
    Projects are to be consistent with the goals of HHS'' National 
Organ and Tissue Donation Initiative (``National Initiative'') and have 
solid evaluation components as emphasized during the April 1-2, 1998, 
national conference titled ``Increasing Donation and Transplantation: 
The Challenge of Evaluation'' sponsored by HHS'' Office of the 
Assistant Secretary for Planning and Evaluation with additional support 
provided by the Agency for Health Care Policy and Research and the 
National Institute of Allergy and Infectious Disease of the National 
Institutes of Health. (Copies of the National Initiative Partnership 
Kit, the final conference report, and a review of evaluation issues are 
available on www.organdonor.gov.) Projects can employ qualitative 
studies, quantitative research, or empiric work. As reflected in the 
third goal of the National Initiative, namely to learn more about what 
works to increase donation and transplantation, HHS places a high 
priority on research and evaluation.
    HHS has served, and plans to continue to serve, as a catalyst for 
the field by emphasizing and encouraging carefully designed and 
rigorous evaluation components and research projects to ascertain 
effective interventions for increasing donation. HHS believes that the 
application of tested theoretical approaches and models to donation 
studies that are carefully designed and evaluated can yield instructive 
information for efforts to increase organ and tissue donation.

Eligibility

    The proposed project must be carried out by a consortium of 
relevant entities or organizations, of which one organizational member 
(``the applicant'') carries overall responsibility for project 
leadership and administration of the HRSA grant award. The applicant 
must be a qualified OPO or other nonprofit, private organization. 
Consortium members and roles must be identified in the application. The 
consortium must include at least one organization, group, or individual 
that has research design and evaluation expertise, and at least one 
other organization (e.g., OPO; public health or other Government 
agency; academic institution; hospital, community/migrant health 
center, or other health services delivery site; transplant/donation-
related association or organization; community-based organization; 
faith-based organization). All members of the consortium must have 
substantive involvement in the project. For-profit organizations may 
participate as members of consortia, but not as the applicant.

Performance Measures

    All projects must include rigorous outcome evaluation protocols. 
Outcomes and performance measures must be identified and defined to 
determine effectiveness of the project. Performance measures are 
expected to address one or more of the following outcomes:
    1. Organ procurement rates;
    2. Consent rates and donation;
    3. Number and prevalence of family donation discussions

Funding and Administrative Mechanism

    The administrative and funding mechanism to be used in this program 
will be the Cooperative Agreement (CA). This vehicle allows for greater 
Federal involvement in continuous refinement of the supported projects 
than provided through a grant program. All funded projects will be 
assigned to a Federal project officer for monitoring and guidance. In 
addition, in order to maximize their potential effectiveness, all 
funded projects will be reviewed at a pre-implementation meeting and 
regularly thereafter by a review group consisting of Federal 
representatives, methodology specialists, project directors of all CAs 
supported under this extramural program, and others as identified by 
the Federal Government. The overall purpose of the periodic review 
meetings is to discuss each project's progress toward its goals, 
problem areas if any, and strategies for increasing the efficacy of 
each project. The group will review and provide comment on issues such 
as the parameters of each project, appropriate outcome and performance 
measures (including base-line data), definitions of terms used to 
describe populations/groups of interest (e.g., potential donor family), 
terms used in the donation process (e.g., ``intent,'' ``consent'', and 
``opportunity'' to donate), and qualitative measurements (e.g., 
``significant'' increase, ``effective'' intervention) to improve the 
usefulness of data collection for individual projects and across 
projects. Final decisions and project direction, however, are the 
responsibility of the Federal project officers. One of the funded 
applicants will receive additional funds to cover costs associated with 
the review group. Such costs may include, but are not limited to, 
expenses related to travel, supplies, and meeting management. 
Applicants interested in performing this function should so indicate in 
the application and state their capabilities.

Review Criteria

    The review of applications will take into consideration the 
proposed criteria listed below. The system used by the peer review 
panel for scoring each application will range from 0-100 points, with 
100 being best. Maximum points that can be awarded for each criterion 
are in parentheses. Separate ranking lists will be employed for 
projects in each of the two phases.
    1. Potential of the project to yield a demonstrable and verifiable 
impact on organ donation and/or the other performance measures. (30 
points)
    2. Extent to which projects are replicable, transferable, and 
feasible in practice for entities with similar competencies (e.g., 
human resources, funding, technology) and for entities targeting 
populations with similar socio-demographic profiles. (15 points)
    3. Degree of scientific rigor in the design, implementation, and 
evaluation of the project. (20 points)
    4. Evidence of the availability of in-kind support, facilities, 
resources, and collaborative arrangements commensurate with the goals 
of the project and the extramural program. (10 points)
    5. Adequacy and experience of project staff. (10 points)
    6. Projects costs that are commensurate with proposed activities 
and anticipated outcomes, and adequacy of budget. (15 points)

Funding Factors

    Two funding priorities are proposed for this program. Approved 
applications

[[Page 16475]]

that are eligible for the funding priorities are awarded additional 
points towards their final rank order score. The largest number of 
funding priority points is proposed for applications that are most 
likely to have a demonstrable impact on consent rates. Five (5) points 
will be awarded for this funding priority. Funding priority is also 
proposed for projects that address variations in consent by race and 
ethnicity, which may include an examination of differences in donation/
transplantation knowledge, attitudes, and experiences among one or more 
minority groups. Two (2) points will be awarded for this funding 
priority. For applications that qualify, Government program staff will 
add the appropriate points to the score assigned by the peer review 
panel. (Maximum total points any application can achieve for all review 
criteria will be 107.)
    HRSA reserves the option to fund a balance of projects in Phases 1 
and 2.

Project Period

    Projects will be awarded for up to 3 years.

Estimated Amount Available For This Competition

    HRSA expects to award under this program up to $5 million in FY99 
to support the first year of approximately 15-20 projects. Subsequent 
years' funding depends on the availability of appropriations, program 
priorities, and recipient performance.

    Dated: March 30, 1999.
Claude Earl Fox,
Administrator.
[FR Doc. 99-8175 Filed 4-2-99; 8:45 am]
BILLING CODE 4160-15-P