Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Health Resources and Services Administration 

# AGENCY:

Health Resources and Services Administration (HRSA), HHS. 

# ACTION:

Request for information.

# 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:                         *jbowman@hrsa.gov.*

*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