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| 93.134 GRANTS TO INCREASE ORGAN DONATIONS |
| FEDERAL AGENCY |
| HEALTH RESOURCES AND SERVICES ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES |
| AUTHORIZATION |
| Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation: Section 377 of the Public Health Service (PHS) Act, 42 U.S.C. Section 274f. Clinical Interventions to Increase Organ Procurement (CIOP): Section 377A of the Public Health Service (PHS) Act, 42 U.S.C. Section 274f-1. Social and Behavioral Interventions to Increase Solid Organ Donation: Section 377A of the Public Health Service (PHS) Act, 42 U.S.C. Section 274f-1. State Donor Registry Support Program and Public Education Efforts to Increase Solid Organ Donation: Section 377A of the Public Health Service (PHS) Act, 42 U.S.C. Section 274f-1. Public Education Efforts to Increase Solid Organ Donation: Section 377A of the Public Health Service (PHS) Act, 42 U.S.C. Section 274f-1. Grants to Establish Programs Coordinating Organ Donation Activities of Hospitals and Organ Procurement Organizations: Section 377B of the Public Health Service Act, 42 U.S.C. Section 274f-2. |
| OBJECTIVES |
| To support grants for the purpose of increasing public commitment to organ donation and the number of organs recovered and ultimately transplanted. To that end, the Division of Transplantation has a cooperative agreement and 5 grant programs with the following objectives: Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation: The purpose of this program is to establish and operate a national system to provide reimbursement of travel and subsistence expenses, and other non-medical expenses that may be authorized by the Secretary to individuals making living donations of their organs. Clinical Interventions to Increase Organ Procurement (CIOP): This program provides support for the implementation and evaluation of model interventions for identifying appropriate heart beating and non-heart-beating donation candidates, evaluating donated organs, maintaining donor stability, and optimizing methods for organ procurement. In FY 2007, the sole focus of the CIOP was to provide support for model interventions for increasing organ donation from uncontrolled donors after cardiac death (UDCD). In FY 2008 the CIOP focus returned to Donation after Neurological Death (DND) and Donation after Cardiac Death (DCD) both controlled and uncontrolled. The FY 2009 focus will again be on DND and DCD. Support would also be likely for hypothesis driven testing of emerging technologies that may be useful for evaluating and improving organ function. Social and Behavioral Interventions to Increase Solid Organ Donation: This program provides support for the implementation and rigorous evaluation of highly promising strategies and approaches for increasing public attitudes, practices and ultimately commitment to organ donation as well as family consent at a relative's time of death. State Donor Registry Support Program: This program provides support to units of State government to develop or improve a statewide electronic registry in which residents can indicate their intent to be a donor which can be accessed by procurement personnel on a 24/7 basis to determine donation wishes of residents at their time of death. The ultimate objective is to ensure that every American has the opportunity to designate his or her donation wishes in a manner that is consistently available when needed. Public Education Efforts to Increase Solid Organ Donation: The purpose of this program is to support the implementation of public education and outreach programs that show promise of increasing organ donation. Specifically, this program supports the replication of strategies demonstrated in the Division's grant program Social and Behavioral Interventions to Increase Solid Organ Donation or through other research efforts to be effective in increasing organ donation. The program also supports the implementation of efforts to increase organ donation that adopt and replicate strategies demonstrated in the public health literature as being effective methods for modifying other health behaviors. The program also supports the implementation of public education and outreach efforts that are based on an established framework for successful public health outreach programs. This grant program is supportive of the Division's mission to educate the public about deceased and/or living donation and to encourage individuals' to document their decision to be a donor in their statewide donor registry or by some other mechanism where a registry is unavailable. Grants to Establish Programs Coordinating Organ Donation Activities of Hospitals and Organ Procurement Organizations: This grant program provides support to teams of OPOs and hospitals in the same donation service area (DSA) to implement and better coordinate strategies for increasing their rates of organ donation and consequently, the number of lives saved through transplantation. |
| TYPES OF ASSISTANCE |
| Project Grants. |
| USES AND USE RESTRICTIONS |
| Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation: Funds made available through this program may not be made available to donating individuals when payment for qualified reimbursement expenses has been made, or can reasonably be expected to be made: (1) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; (2) by an entity that provides health services on a prepaid basis; or (3) by the recipient of the organ. All Other Programs: Funds may not be used for activities that are reimbursable under Medicare. |
| Applicant Eligibility |
| Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation: As specified in Section 377 of the Public Health Service Act, as amended, eligible applicants include States, transplant centers, qualified organ procurement organizations under section 371, or other public or private entities. Clinical Interventions to Increase Organ Procurement Grant Program (CIOP): As specified in Section 377A (b) of the Public Health Service Act, as amended, the Secretary may make peer-reviewed grants to public and nonprofit private entities. If the applicant is an OPTN member, and if the applicant is working with a consortium that includes OPTN members, the applicant and all other OPTN members are expected to be in compliance with the final rule governing the operation of the OPTN Section 121.11(b2). Social and Behavioral Interventions to Increase Solid Organ Donation Grant Program: As specified in Section 377A(b) of the Public Health Service Act, as amended, the Secretary may make peer-reviewed grants to public and nonprofit private entities for the purpose of carrying out studies and demonstration projects to increase organ donation and recovery rates, including living donation. If the applicant is an OPTN member, and if the applicant is working with a consortium that includes OPTN members, the applicant and all other OPTN members are expected to be in compliance with the final rule governing the operation of the OPTN Section 121.11(b2). State Donor Registry Support Program: As specified in Section 377A(c) of the Public Health Service Act, as amended, the Secretary may make peer-reviewed grants to States for activities pertaining to the State donor registry. If the applicant is working with a consortium, any consortium members that are OPTN members are expected to be in compliance with the final rule governing the operation of the OPTN Section 121.11(b2). Public Education Efforts to Increase Solid Organ Donation: As specified in Section 377A(b) of the Public Health Service Act, as amended, the Secretary may make peer-reviewed grants to public and nonprofit private entities for the purpose of carrying out studies and demonstration projects to increase organ donation and recovery rates, including living donation. If the applicant is an OPTN member, and if the applicant is working with a consortium that includes OPTN members, the applicant and all other OPTN members involved in the project are expected to be in compliance with the final rule governing the operation of the OPTN Section 121.11(b2). Grants to Establish Programs Coordinating Organ Donation Activities of Hospitals and Organ Procurement Organizations: As specified under section 377B of the Public Health Service Act, the Secretary may award grants to qualified organ procurement organizations and hospitals under section 371 to establish programs coordinating organ donation activities of eligible hospitals and qualified organ procurement organizations under section 371. For purposes of this section, eligible hospital means a hospital that performs significant trauma care, or a hospital or consortium of hospitals that serves a population base of not fewer than 200,000 individuals. |
| Beneficiary Eligibility |
| Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation: Primary beneficiaries are low/moderate income living organ donors and recipients. All other Programs: Beneficiaries are all organ transplant recipients. |
| Credentials/Documentation |
| Applicants should review the individual HRSA Guidance documents issued under this CFDA program for any required proof or certifications which must be submitted prior to or simultaneous with submission of an application package. |
| Preapplication Coordination |
| This program is eligible for coverage under E.O. 12372, "Intergovernmental Review of Federal Programs." An applicant should consult the office of the official designated as the single point of contact in his or her State for more information on the process the State requires to be followed in applying for assistance, if the State has selected the program for review. |
| Application Procedure |
| Grant applications and required forms for this program can be obtained from Grants.gov. Please visit the Grants.gov Web site at www.grants.gov to both find and apply for all Federal grant opportunities. All qualified applications will be forwarded to an objective review committee which will make funding recommendations to the Associate Administrator for the Bureau of Healthcare Systems. The Associate Administrator has the authority to make final selections for awards. |
| Award Procedure |
| Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation: Applications are reviewed by a committee of representatives with diverse expertise including organ transplantation. Applications are reviewed for merit. Final decisions are made by the Associate Administrator for the Bureau of Healthcare Systems. Clinical Interventions to Increase Organ Procurement Grant Program: Applications are reviewed by a committee of representatives knowledgeable about organ donation and transplantation. Applications are reviewed for merit. Final decisions are made by the Associate Administrator for the Bureau of Healthcare Systems. Social and Behavioral Interventions to Increase Organ Donation Grant Program: Applications are reviewed and scored for merit by a committee of representatives knowledgeable about strategies to increase organ donation and evaluation research methodology. Final decisions are made by the Associate Administrator for the Bureau Healthcare Systems. State Donor Registry Support Program: Applications are reviewed and scored for merit by a committee of individuals with expertise and experience in statewide organ donor registries and evaluation processes. Final decisions are made by the Associate Administrator for the Bureau of Healthcare Systems. Public Education Efforts to Increase Solid Organ Donation Grant Program: Applications are reviewed and scored for merit by a committee of individuals with expertise in organ donor awareness strategies and applied evaluation methodologies. Applications are reviewed and scored for merit. Final decisions are made by the Associate Administrator for the Bureau of Healthcare Systems. Grants to Establish Programs Coordinating Organ Donation Activities of Hospitals and Organ Procurement Organizations: Applications are reviewed and scored for merit by a committee of representatives knowledgeable about strategies to increase organ donation. Final decisions are made by the Associate Administrator for the Bureau of Healthcare Systems. |
| Deadlines |
| www.hrsa.gov. |
| Range of Approval/Disapproval Time |
| From 30 to 90 days. |
| Appeals |
| None. |
| Renewals |
| None. |
| Formula and Matching Requirements |
| None of the grant programs has a statutory formula. The Grants to Establish Programs Coordinating Organ Donation Activities of Hospitals and Organ Procurement Organizations Program has a matching requirement of not less than 30% of the amount of the grant awarded. |
| Length and Time Phasing of Assistance |
| The Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation Cooperative Agreement is awarded for a 12-month budget period over a four-year period. Both Clinical Interventions Research grants and Social and Behavioral Research grants are awarded for a 12-month budget period over a three-year period. State Donor Registry Support Program grants are awarded for a 12-month budget period over a one-year period. Public Education Efforts to Increase Solid Organ Donation are awarded for a 12-month budget period over a two year period. Grants to Establish Programs Coordinating Organ Donation Activities of Hospitals and Organ Procurement Organizations are awarded for a 12-month budget period over a two-year period. |
| Reports |
| Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation: Two progress reports are required in addition to annual financial reports. Final reports and final financial status reports are due 90 days from the end of the project period. Clinical Interventions to Increase Organ Procurement Grant Program: Quarterly progress reports are required for all awardees in addition annual financial reports. Final progress reports and final financial status reports are due 90 days from the end of the project period. Social and Behavioral Interventions to Increase Organ Donation Grant Program: Two progress reports are required for all awardees in addition to annual financial reports. Final reports and final financial status reports are due 90 days from the end of the project period. State Donor Registry Support Program: One progress report is required for all awardees in addition to annual financial reports. Final reports and final financial status reports are due 90 days from the end of the project period. Public Education Efforts to Increase Solid Organ Donation: Two progress reports are required for all awardees in addition to annual financial reports. Final reports and final financial status reports are due 90 days from the end of the project period. Grants to Establish Programs Coordinating Organ Donation Activities of Hospitals and Organ Procurement Organizations: Two progress reports are required for all awardees in addition to annual financial reports. Final reports and final financial status reports are due 90 days from the end of the project period. |
| Audits |
| In accordance with the provisions of OMB Circular No. A-133 (Revised, June 27, 2003), "Audits of States, Local Governments, and Nonprofit Organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $500,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. |
| Records |
| All records must be maintained until expiration of 3 years from the date of submission of the final expenditure report. If questions remain following the 3-uear period, such as those raised as a result of an audit or an on-going enforcement action, recipients must retain records until the matter is completely resolved. |
| Account Identification |
| 75-0350-0-1-550. |
| Obligations |
| 122 Obligations: Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation: FY 07 $500,000; FY 08 $0; FY 09 est. $2,000,000 Clinical Interventions to Increase Organ Procurement Grant Program: FY 07 $757,445; FY 08 est. $1,952,844; and FY 09 est. $2,841,654. Social and Behavioral Interventions to Increase Organ Donation Grant Program: FY 07 est. $3,690,372; FY 08 est. $3,809,461; and FY 09 est. $3,695,645. State Donor Registry Support Program: FY 07 $467,510; FY 08 est. $600,000; and FY 09 est. $500,000. Public Education Efforts to Increase Organ Donation: FY 07 est. $1,300,698; FY 08 $1,945,090; and FY 09 est. $1,662,830. Grants to Establish Programs Coordinating Organ Donation Activities of Hospitals and Organ Procurement Organizations: FY 07 $161,180. |
| Range and Average of Financial Assistance |
| Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation: $2,000,000 Clinical Interventions to Increase Organ Procurement Grant Program: $286,974 to $626,740; $379,329. Social and Behavioral Interventions to Increase Organ Donation Grant Program: $65,000 to $585,761; $226,789. State Donor Registry Support Program: $97,872 to $175,725; $145,352 Public Education Efforts to Increase Organ Donation: $206,362 to $413,360; $328,294.75. Grants to Establish Programs Coordinating Organ Donation Activities of Hospitals and Organ Procurement Organizations: $45,000 to $63,382; $79,453. |
| PROGRAM ACCOMPLISHMENTS |
| Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation: In FY 06, a cooperative agreement was awarded to the Regents of the University of Michigan to establish and operate the program through September 30, 2010. The Regents of the University in collaboration with the American Society of Transplant Surgeons established the National Living Donor Assistance Center to operate the Program. The Program Eligibility Guidelines were approved and published in the Federal Register in October 5, 2007. The Program Website, www.livingdonorassistance.org was launched in October 17, 2007. As of April 30, 2008, approximately 100 prospective living donors have applied for assistance from NLDAC. Clinical Interventions to Increase Organ Procurement Grant Program: There were no new grants funded in FY 2006 (CIOP). CIOP final reports were submitted in 2007. A grant related manuscript is to be soon published by the New England Journal of Medicine. In FY 2007 the CIOP was released with a new focus on uncontrolled donation after cardiac death (UDCD), and two grants were awarded. For FY 2008 there are 12 applications involving DCD and DND that are to be submitted to the grant review process. Social and Behavioral Interventions to Increase Solid Organ Donation Grant Program: In FY 05, 13 noncompeting and 5 competing awards were made; in FY 2006, 12 non-competing and 6 competing awards were made. In FY 2007, 10 non-competing awards and 5 competing awards were made. Thirteen applications were submitted for competitive review in FY 2008. State Donor Registry Support Program: In FY 2006, one competing award was made; in FY 2007, 4 awards were made. Five applications were submitted for competitive review in FY 2008. Public Education Efforts to Increase Solid Organ Donation: In FY 2007, 4 awards were made. Eight applications were submitted in FY 2008 with two awards made. Grants to Establish Programs Coordinating Organ Donation Activities of Hospitals and Organ Procurement Organizations: In FY 2006, there were 4 non-competing and 3 competing awards were made. In FY 2007, 3 non-competing awards and no new awards were made. |
| REGULATIONS, GUIDELINES, AND LITERATURE |
| This program is subject to the provisions of 45 CFR Part 92 for State, local and tribal governments and 45 CFR Part 74 for institutions of higher education, hospitals, other nonprofit organizations and commercial organizations, as applicable. |
| Regional or Local Office |
| Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation: Mesmin Germain, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 12C-06, Rockville, MD 20857. Telephone: (301) 443-0053. Clinical Interventions to Increase Organ Procurement Grant Program: Bernard Kozlovsky, MD, MS, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 12C-06, Rockville, MD 20857. Telephone: (301) 443-0565. Social and Behavioral Interventions to Increase Organ Donation Grant Program and Public Education Efforts to Increase Solid Organ Donation: Madeleine Hess, PhD, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 12C-06, Rockville, MD 20857. Telephone: (301) 443-6866. State Donor Registry Support Program: Venus Walker, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 12C-06, Rockville, MD 20857. Telephone: (301) 443-7578. Public Education Efforts to Increase Solid Organ Donation: Madeleine Hess, PhD, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 12C-06, Rockville, MD 20857. Telephone: (301) 443-6866. Grants to Establish Programs Coordinating Organ Donation Activities of Hospitals and Organ Procurement Organizations: Madeleine Hess, PhD, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 12C-06, Rockville, MD 20857. Telephone: (301) 443-6866. |
| Headquarters Office |
| Grants Management Office: Rick Goodman, Director, Division of Grants Management Operations, Health Resources and Services Administration, Department of Health and Human Services, 5600 Fishers Lane, Room 11A-16. Health Services Branch: Telephone: (301) 443-2385; Research and Training Branch: Telephone: (301) 443-3099; Government and Special Focus Branch: Telephone: (301) 443-3288. |
| Web Site Address |
| www.hrsa.gov |
| RELATED PROGRAMS |
| None. |
| EXAMPLES OF FUNDED PROJECTS |
| Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation: The funded project will establish and operate a National system to provide reimbursement of travel and subsistence expenses to individuals making living donations of their organs. Clinical Interventions to Increase Organ Procurement Grant Program: Funded projects include such interventions such as pulsatile perfusion of kidneys, pulsatile perfusion in the expanded kidney donor, chest wall oscillation to improve quantity and quality of brain dead heart beating donor lungs and validation of identification criteria for DCD donors. FY 2007 awards will be focused on uncontrolled donation after cardiac death (UDCD). Social and Behavioral Interventions to Increase Organ Donation Grant Program: Funded projects include social and behavioral interventions to promote awareness of the need for donors and commitment to organ donation through the workplace, in schools, and on Native American Indian reservations, and projects to increase the number of dialysis patients who are aware of their option to identify a living donor. State Donor Registry Support Program: The funded project will develop and launch a statewide registry in Kentucky in which residents can indicate their intent to be organ, tissue, and eye donors. Grants to Establish Programs Coordinating Organ Donation activities of Hospitals and Organ Procurement Organizations: The funded projects provide for the availability of trauma and acute hospital's to support in-house organ donation program coordinators to increase or maintain an organ donation conversion rate of 75 percent through improved identification and referral of potential donors, improved effective requesting, especially to improve minority conversion rates and to implement donation following cardiac death, resulting in increased numbers of transplantable organs from single donors. These project goals are consistent with the IHI Donation Breakthrough Collaborative and awardees will provide both quantitative and qualitative data at the end of the project period. |
| CRITERIA FOR SELECTING PROPOSALS |
| Please refer to the Program Guidance. |
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General Services Administration Office of Chief Acquisition Officer Regulatory and Federal Assistance Division (VIR) |
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