[Federal Register Volume 75, Number 185 (Friday, September 24, 2010)]
[Notices]
[Page 58400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23893]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Donor Management Research: Improvements in Clinical Management of
Deceased Organ Donors
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Request for information.
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SUMMARY: The Health Resources and Services Administration (HRSA),
Division of Transplantation, is soliciting input, feedback, and
suggestions from researchers and interested parties within the organ
donation and transplant community regarding guidance for a possible
grant or contract that focuses on improvements in clinical management
of deceased organ donors.
Given the continued imbalance between the demand for and supply of
deceased donor organs, it is essential that deceased donors be managed
appropriately to optimize the number and function of donor organs. It
is reasonable to expect that better clinical donor management would
improve organ quality, organs transplanted per donor (OTPD), and post-
transplant recipient outcomes.
DATES: Written or electronic comments must be received by HRSA by
October 15, 2010.
ADDRESSES: Please send all written comments to James Bowman, MD Medical
Director, Division of Transplantation, Healthcare Systems Bureau,
Health Resources and Services Administration, 5600 Fishers Lane, Suite
12C-06, Rockville, Maryland 20857; Telephone (301) 443-4861 Fax (301)
594-6095; or e-mail: [email protected].
Docket: For access to the docket to view comments received, phone
301-443-7577 to schedule an appointment to view public comments.
FOR FURTHER INFORMATION CONTACT: James Bowman, MD, Medical Director at
Division of Transplantation, Healthcare Systems Bureau, Health
Resources and Services Administration, at the contact information cited
above.
SUPPLEMENTARY INFORMATION:
Background
Since 2002, HRSA has funded the Clinical Interventions to Increase
Organ Procurement (CIOP) Grant Program, authorized by Public Health
Service Act, as amended, Section 377A(b), (42 U.S.C. 274f-1). The CIOP
Grant Program has provided support for the implementation and
evaluation of highly promising strategies and approaches serving as
model interventions for identifying appropriate organ donor candidates,
evaluating donated organs, maintaining donor clinical stability and
optimizing methods for organ procurement. Other than the fiscal year
2007 CIOP grant cycle, which focused on uncontrolled donation after
circulatory death donors, the CIOP Program has not focused on specific
research issues. Since the inception of the grant program, 19 grants
have been awarded. While these grants have furthered knowledge
regarding clinical management of donors, the studies have generally
focused on specific organ systems and not on donor management
approaches with the goal of optimizing all organ systems.
The CIOP Grant Program was not funded in Fiscal Year 2010 to allow
HRSA to consider how to best utilize the limited Federal research funds
available in a more useful and beneficial manner. There has been
considerable discussion among critical care and transplant specialists
regarding donor management. A Donor Management Task Force was convened
in August 2010 to address relevant issues in donor management
practices. This task force discussed: (1) Advancing the scientific
knowledge that influences organ donor management practices; (2)
promoting the adoption of critical care and quality improvement
practices in each Donation Service area (DSA) that optimize organ
viability and increase OTPD; (3) ensuring that all patients meeting the
neurologic criteria for determination of death are pronounced in a
timely manner so that organ donation intentions may be fully honored;
and (4) ensuring that each donation case occurs using the most
appropriate donation pathway: Either donation after neurologic
determination of death or donation after cardiac determination of
death. Although quality donor management may be assumed to improve
transplantation outcomes, there are limited scientifically rigorous
studies validating this assumption. The studies that do exist involve a
limited number of DSAs. These studies do suggest an improvement in OTPD
based on certain donor management practices, but further investigation
is needed. Upon review of research possibilities being discussed in
meetings and in the literature, HRSA believes that research should be
directed to help establish evidence-based donor management protocols.
Therefore HRSA is considering funding through a grant or contract
mechanism to one or two parties, a total of up to $1 million/year for
three (3) years to conduct a multicenter, nationwide study focused on
donor management and improvement in outcomes, particularly OTPD, organ
quality, and post-transplant recipient outcomes.
Request for Comments
For this Request for Information, respondents are asked to present
their experiences and opinions regarding the importance of further
study into donor management and its outcomes. Suggestions and comments
concerning specific areas of analysis are encouraged. Such studies
might consider developing or refining a validated tool useful for
predicting donor outcomes based upon appropriate and readily available
donor data (e.g., collected for purposes of OPTN data submission, or
routinely collected by Organ Procurement Organizations). Donor
management study designs that include OPTN data collected on most, if
not all, deceased donor organs will be encouraged.
HRSA is seeking guidance from the community to help structure
either a donor management study to be accomplished by contract or
targeted research questions that will be incorporated into the CIOP FY
2011 request for application.
Dated: September 16, 2010.
Mary K. Wakefield,
Administrator.
[FR Doc. 2010-23893 Filed 9-23-10; 8:45 am]
BILLING CODE 4165-15-P