[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]
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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.
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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
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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
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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
