Document ID: FDA-2014-N-0012-0001
Agency: fda
Document Type: Notice
Title: Kidney Health Initiative (R18)
Posted Date: 2014-06-10T04:00Z

[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Notices]
[Pages 33201-33203]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13443]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0012]

Kidney Health Initiative (R18)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of grant funds for the support of the Center for Drug 
Evaluation and Research/Office of Medical Policy's Kidney Health 
Initiative Program. FDA, Center for Drug Evaluation and Research 
(CDER), Office of Medical Policy (OMP) is announcing its intent to 
accept and consider a single source application for the award of a 
grant to the American Society of Nephrology (ASN) to support the Kidney 
Health Initiative (KHI).

DATES: The application due date is June 30, 2014, by 11:59 p.m., EST.

ADDRESSES: Submit electronic applications to: http://www.grants.gov.

[[Page 33202]]

For more information, see section III of the SUPPLEMENTARY INFORMATION 
section of this notice.

FOR FURTHER INFORMATION CONTACT: Mark Lauda, Office of Medical Policy, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
White Oak, Bldg. 51, Rm. 2212, Silver Spring, MD 20993, 301-796-0381, 
email: Mark.Lauda@fda.hhs.gov; or Lisa Ko, Office of Acquisition & 
Grants Services, Food and Drug Administration, 5630 Fishers Lane, 
Rockville, MD, 240-402-7592, email: Lisa.Ko@fda.hhs.gov.
    For more information on this funding opportunity announcement (FOA) 
and to obtain detailed requirements, please refer to the full FOA 
located at http://www.grants.gov. Search by Funding Opportunity Number: 
RFA-FD-14-018.

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description

RFA-FD-14-018
    93.103

A. Background

    A memorandum of understanding (MOU) between FDA and ASN signed in 
September 2012 served as the basis for the establishment of KHI. This 
award will be made to ASN to enable FDA's support of KHI by defraying 
some of the direct and indirect costs associated with KHI and KHI 
projects. The ASN is a 501(c)(3) non-profit organization whose mission 
is to fight against kidney disease by educating health professionals, 
sharing new knowledge, advancing research, and advocating the highest 
quality care for patients.
    KHI is a public-private partnership whose mission is to advance 
scientific understanding of the kidney health and patient safety 
implications of new and existing medical products and to foster 
development of therapies for disease that affect the kidney by creating 
a collaborative environment in which FDA and the greater nephrology 
community can interact to optimize evaluation of drugs, devices, 
biologics, and food products. KHI membership is broad and includes 
stakeholders from government, patient advocacy groups and foundations, 
pharmaceutical and device companies, professional societies, dialysis 
providers, and research institutions. KHI helps to effect change 
through the conduct of projects that address barriers to innovation, 
facilitate critical evidence generation, and/or elucidate safety 
concerns. KHI projects may be submitted for consideration by any of its 
member organizations (including FDA). Candidate projects are developed 
and refined through Web-based interactions and during stakeholder 
meetings. Candidate projects that are successfully developed and 
receive the endorsement of the KHI Board of Directors are conducted on 
a volunteer basis by work groups largely (but not exclusively) staffed 
by individuals from KHI member organizations.
    The opportunity for meaningful interaction with a broad set of 
stakeholders committed to improving the evaluation of products that 
impact kidney health offers significant value to FDA and the public. 
Since its inception, KHI has undertaken several projects that have 
advanced the FDA mission, including (but not limited to) projects 
elucidating endpoints for lupus nephritis trials and also providing 
guidance for generating pharmacokinetic data for critical drugs often 
used in the setting of continuous renal replacement therapies.

B. Research Objectives

    The goals of this program are to develop and maintain an 
administrative and scientific infrastructure to support the creation 
and execution of a series of projects under the auspices of KHI, to 
complement the goals of FDA.
    The following KHI activities are supported by this grant:
     Maintaining an adequate administrative and scientific 
infrastructure to implement all related projects under this 
collaborative effort.
     Identifying and/or hiring a sufficient number of qualified 
personnel to conduct the necessary research and project-management of 
all related activities, including review of project milestones for 
degree of completion, preparation/reporting of project findings, 
periodic and final reports, and subsequent distribution in the public 
domain.
     Developing plans for the conduct of identified research 
plans.
     Identifying, securing, and/or building, and effectively 
leveraging other resources for the conduct of identified projects.
     Upon completion of a given project, generating project 
results and recommendations and proposing related studies/projects, if 
needed, to build on the findings of the project and continuing to 
leverage established resources and personnel.

C. Eligibility Information

    The following organization is eligible to apply: American Society 
of Nephrology (ASN).

II. Award Information/Funds Available

A. Award Amount

    This is a multi-year grant. FDA/CDER intends to fund up to $500,000 
in total costs (direct and indirect) in fiscal year (FY) 2014. Awards 
are contingent upon the availability of funds.
    Subject to the availability of Federal funds and successful 
performance of the FOA's stated goals and objectives, 4 additional 
years of support may be available. Funding beyond the first year will 
be noncompetitive and will depend on: (1) Satisfactory performance 
during the preceding year and (2) the availability of Federal FY funds.
    Application budgets need to reflect the actual needs of the 
proposed project and should not exceed the following in total costs 
(direct and indirect):

Year 1: $500,000
Year 2: $500,000
Year 3: $500,000
Year 4: $500,000
Year 5: $500,000

B. Length of Support

    The scope of the proposed project should determine the project 
period. The maximum project period is 5 years.

III. Electronic Application, Registration, and Submission

    Only electronic applications will be accepted. To submit an 
electronic application in response to this FOA, applicants should first 
review the full announcement located at http://www.grants.gov. Search 
by Funding Opportunity Number: RFA-FD-14-018. (FDA has verified the Web 
site addresses throughout this document, but FDA is not responsible for 
any subsequent changes to the Web sites after this document publishes 
in the Federal Register.) For all electronically submitted 
applications, the following steps are required.

 Step 1: Obtain a Dun and Bradstreet (DUNS) Number
 Step 2: Register With System for Award Management (SAM)
 Step 3: Obtain Username & Password
 Step 4: Authorized Organization Representative (AOR) 
Authorization
 Step 5: Track AOR Status
 Step 6: Register With Electronic Research Administration (eRA) 
Commons

    Steps 1 through 5, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in 
detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed 
these steps, submit

[[Page 33203]]

electronic applications to: http://www.grants.gov.

    Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13443 Filed 6-9-14; 8:45 am]
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