[Federal Register Volume 67, Number 90 (Thursday, May 9, 2002)]
[Notices]
[Pages 31349-31351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-11580]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Extramural Support Program for Projects To Increase Organ 
Procurement

AGENCY: Health Resources and Services Administration, Health and Human 
Services.

ACTION: Notice of availability of funds.

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SUMMARY: The Health Resources and Services Administration (HRSA) 
announces the availability of fiscal year (FY) 2002 funds to be awarded 
under the Division of Transplantation (DoT) program for discretionary 
grants, under a new competition that supports the evaluation of 
clinical interventions to increase the number of heart-beating and non-
heart-beating organ donors and/or the number of organs that could be 
recovered from such donors. In concert with HHS' Gift of Life Donation 
Initiative, this extramural program, Clinical Interventions to Increase 
Organ Procurement, will fund grants 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 
organ procurement and which are replicable, transferable, and feasible 
in practice. Applicants must be qualified organ procurement 
organizations (OPOs) or other nonprofit private organizations actively 
involved in the field of transplantation. 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 help HRSA adequately plan for the Objective Review Process, 
Letters of Intent are encouraged from all applicants. Such letters 
should be sent to: Lynn Rothberg Wegman, M.P.A., Director, Division of 
Transplantation, Office of Special Programs, Health Resources and 
Services Administration, 5600 Fishers Land, Room 7C-22, Rockville, 
Maryland 20857, or faxed to: 301/594-6095 or 301/443-1267. Such letters 
should be received by DoT by June 10, 2002. Receipt of these notices of 
intent will not be routinely acknowledged.

EFFECTIVE DATE: Applications must be received in the HRS Grant 
Application Center by the close of business July 8, 2002, to be 
considered for competition. Applications will meet the deadline if they 
are either (1) received on or before the deadline date or (2) 
postmarked on or before the deadline date, and received in time for 
submission to the objective review panel. A legibly dated receipt from 
a commercial carrier or U.S. Postal Service will be accepted instead of 
a postmark. Private metered postmarks shall not be accepted as proof of 
timely mailing. Applications postmarked after the deadline will be 
returned to the applicant.

ADDRESSES: The official grant application kit and guidance materials 
for this announcement may be obtained on the following three web sites: 
www.hrsa.gov, www.hrsa.gov/osp/dot/, and www.organdonor.gov, and from 
the HRSA Grants Application Center, Attn: CFDA 93.134; 2002 Clinical 
Interventions to Increase Organ Procurement, The Legin Group, Inc., 901 
Russell Avenue, Suite 450, Gaithersburg, MD 20879; telephone 877/477-
2123, e-mail address [email protected]. Applicants are strongly advised 
to obtain the Guidance before preparing applications. Applicants for 
grants will use Revised Form PHS 5161-1. This form may be downloaded 
from the DHHS Program Support Center (PSC) website at: 
http://www.psc.gov/forms/PHS/phs.html. The application guidance may be 
accessed through HRSA's website at www.hrsa.gov/grants.htm.

FOR FURTHER INFORMATION CONTACT: Additional information regarding 
business, administrative, and fiscal issues related to the awarding of 
grants under this Notice may be requested from Darren S. Buckner, 
Grants Management Specialist, HIV/AIDS Bureau, Health Resources and 
Services Administration, 5600 Fishers Land, Room 7-89, Rockville, MD 
20857; telephone 301/443-1913; fax 301/594-6096; e-mail address 
[email protected].
    Additional information regarding program issues and the overall 
Program may be requested from Laura M. Saint Martin, M.D., M.P.H., 
Medical Officer, or Virginia McBride, R.N., B.S., CPTC, Public Health 
Analyst, Operations and Analysis Branch, Division of Transplantation, 
Office of Special Programs, Health Resources and Services 
Administration, 5600 Fishers Land, Room 7C-22, Rockville, MD 20857; 
telephone number 301/443-

[[Page 31350]]

7577; fax 301/594-6095 or 301/443-1267. Dr. Saint Martin can be reached 
via e-mail at [email protected]; Ms. McBride can be reached at 
[email protected].
    Technical assistance regarding this funding announcement may be 
requested from Virginia McBride, R.N., B.S., CPTC, Public Health 
Analyst, Operations and Analysis Branch, Division of Transplantation, 
Office of Special Programs, Health Resources and Services 
Administration, 5600 Fishers Lane, Room 7C-22, Rockville, MD 20857; fax 
301/594-6095 or 301/443-1267; e-mail address [email protected].

SUPPLEMENTARY INFORMATION:

Purposes

    Organ donation has become an increasingly important public health 
issue. Only about 6,000 deaths in the United States each year result in 
organ donation, compared with an estimated potential of 8,000-15,000 
donors. Moreover, nearly 80,000 patients are currently awaiting 
transplants and about 5,500 patients die each year because of the 
critical shortage of transplantable organs.
    In September 1999, HRSA's Division of Transplantation (DoT) 
instituted its Model Interventions to Increase Donation grant program 
that focused on interventions to increase cadaveric organ and tissue 
donation. In 2001, the program was expanded to include interventions to 
increase living donation and the development of hospital donor 
protocols and educational interventions to increase non-heart-beating 
donation. To be considered eligible, interventions must be intended to 
increase organ procurement, raise consent rates for organ donation, 
and/or increase the rate of declaration of intent to donate coupled 
with family notification of intent to become an organ donor.
    To date, interventions funded by DoT's grant program that address 
the first criterion, increasing organ procurement, have focused on 
improving hospital and OPO interactions/practices to identify donors 
and provide emotional support to donor families. However, additional 
opportunities to increase the rate of organ procurement exist but 
continue to fall outside the scope of HRSA's current grant program. In 
fact, many interventions that would likely increase organ procurement 
efficiency do not appear to qualify for any HHS funding opportunities 
possibly because the research would need to be conducted after 
pronouncement of a donor's death.
    For this reason, DoT is proposing the development of a new grant 
program, Clinical Interventions to Increase Organ Procurement, to 
support the evaluation of clinical interventions to increase the number 
of heart-beating and non-heart-beating organ donors and/or the number 
of organs that could be recovered from such organ donors. Eligible 
interventions could focus on new and/or improved methods to optimize 
hemodynamic stability in brain dead patients, improve donor organs with 
compatible recipients. Additionally, projects leading to more accurate 
identification of appropriate non-hear-beating donation candidates and 
improved methods of donor stabilization and organ recovery would 
qualify. Improving OPO internal processes, such as improved quality 
assurance practices, also would be acceptable if it can be demonstrated 
that these efforts result in increased organ procurement.
    This grant program is focused solely on clinical interventions to 
increase heart-beating and non-heart-beating cadaveric donation. Funds 
will not be used for other types of projects. Examples of research that 
will not be supported under this program are: Living donation; clinical 
trials of drugs not approved by the FDA or off-label uses of FDA-
approved drugs; research involving animals; long-term transplantation 
outcomes research; interventions to increase tissue donation alone; 
practices related to the pronouncement of death; and interventions 
inconsistent with Federal law or statute. Projects falling within the 
scope of DoT's grant program, Model Interventions to Increase Organ and 
Tissue Donation, also are not eligible to receive funding under the 
clinical interventions program.
    Projects can employ qualitative studies, quantitative research, or 
empiric work. 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 Healthcare Research and Quality and the National 
Institute of Allergy and Infectious Diseases, 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 and procurement.

Review Criteria

    The review of applications will take into consideration the 
proposed criteria listed below. The system for scoring each application 
will range from 0-100 points, with 100 being best.
    1. (30 points) Potential of the project to yield a demonstrable and 
verifiable impact on organ procurement.
    2. (25 points) Degree of scientific rigor in the design, 
implementation, and evaluation of the project.
    3. (20 points) Experience and expertise of proposed project staff 
as supported by education, relevant publications and work history.
    4. (15 points) Extent to which projects are replicable, 
transferable, and practical.
    5. (10 points) Adequacy of facilities, resources, and collaborative 
arrangements relevant to the goals of the project.

Performance Measures

    All project 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 donation rates;
    2. Organ procurement rates; and/or
    3. Organ transplant rates.

    Availability of Funds: The Clinical Interventions to Increase Organ 
Procurement Program is authorized by Section 371(a)(3) of the Public 
Health Service (PHS) Act, 42 U.S.C. 273(a)(3), as amended. This section 
authorizes the Secretary to make grants to qualified organizations for 
the purpose of carrying out special projects designed to increase the 
number of organ donors.
    HRSA expects to award under this program up to $3 million in FY2002 
to support the first year of approximately 12-20 projects. Subsequent 
years' funding depends on the availability of appropriations, program 
priorities, and recipient performance. Projects will be awarded for up 
to 3 years. The budget and project periods for approved and funded 
projects will begin on or about September 30, 2002. All applicants 
should submit budgets for the three-year period.
    Eligible Applicants: The proposed project may be conducted solely 
by an OPO or 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 Federally designated OPO (section

[[Page 31351]]

1138(b) of the Social Security Act) or other nonprofit private 
organization actively involved in the field of transplantation, or a 
Federal institution in accordance with section 235 of the Public Health 
Service Act. If the consortium approach is used, members and roles must 
be identified in the application and all members must have substantive 
involvement in the project. For-profit organizations may participate as 
members of consortia, but not as the applicant.

    The OMB Catalog of Federal Domestic Assistance number for the 
Clinical Interventions to Increase Organ Procurement Program is 
93.134.

    Paperwork Reduction Act: OMB approval for any data collection in 
connection with these grants will be sought, as required under the 
Paperwork Reduction Act of 1995.

    Dated: April 19, 2002.
Elizabeth M. Duke,
Administrator.
[FR Doc. 02-11580 Filed 5-8-02; 8:45 am]
BILLING CODE 4165-15-U