[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: <a href="/cdn-cgi/l/email-protection#6c060e031b010d022c041e1f0d420b031a"><span class="__cf_email__" data-cfemail="b4ded6dbc3d9d5daf4dcc6c7d59ad3dbc2">[email protected]</span></a>.
    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


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