Grants and cooperative agreements; availability, etc.: Organ and tissue donation; extramural support program,

[Federal Register: April 5, 1999 (Volume 64, Number 64)]

[Notices]

[Page 16473-16475]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr05ap99-92]

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

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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. 99-8175Filed4-2-99; 8:45 am]

   BILLING CODE 4160-15-P