Daily Rules, Proposed Rules, and Notices of the Federal Government
2. The anticipated start date is September 13, 2012.
3. The opening date is July 2, 2012.
4. The expiration date is August, 2, 2012.
For more information on this funding opportunity announcement (FOA) and to obtain detailed requirements, please refer to the full FOA located at:
Annually, millions of patients undergo magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) procedures employing GBCAs. Postmarketing data indicate that six of the eight GBCAs approved for use in the United States have been directly implicated in the development of NSF, a newly characterized, potentially fatal systemic fibrotic skin and internal organ condition. Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of GBCA and degree of renal impairment at the time of exposure; imaging patients with severe renal failure appear to be at highest risk. In one, early retrospective study of 370 patients with severe renal failure who received gadodiamide the estimated risk for development of NSF was 4 percent (Ref. 1). In a recent retrospective chart review study by Wang of 52,954 contrast MR examinations with restrictive guidelines for GBCA in patients with renal failure no new cases of NSF were found (Ref. 2).
In addition, the NSF risk appears to vary among the GBCAs. Postmarketing data and corroborating preclinical data that demonstrated a significant, unacceptable NSF risk has led FDA to recently contraindicate Omniscan, Magnevist, and Optimark for patients with acute kidney injury and severe chronic renal failure. The risk of NSF associated with the remaining marketed GBCAs for patients with these kidney conditions is expected to be lower, but is not fully understood. Therefore, there is a public health need to study the risk of NSF associated with the exposure of those remaining marketed GBCAs and to inform the development of reliable knowledge, practice guidelines, and regulatory processes in relationship to the safety of these agents.
The primary goal of this project is to employ an existing Quality Assurance (QA) registry of patients with renal failure who received GBCAs as the basis for a prospective registry study of the risk of NSF associated with GBCAs among renal patients. Patients already enrolled in this QA registry will be invited to enroll in an outpatient registry to study their risk of NSF. Data from this project will help understand the effect of cumulative dosing of the GBCAs in patients with slow deterioration of renal function as occurs with aging, and the data might also provide further reassurance as to the safety of the GBCAs identified as having minimal association with the risk of NSF by prospectively following patients who have received GBCAs. In addition, the project will also provide data on the occurrence of allergic reactions associated with the GBCA administration. A recent report by Prince suggests an increased risk of allergic reactions with MultiHance (Ref. 3).
The prospective design of this project is important since most previous clinical investigations have been based on chart review or other retrospective data. Implementation of this project may also provide the structure for future prospective investigations of other diseases with an acute phase of hospitalization superimposed on a chronic course.
This is a sole source cooperative agreement to: University of Pittsburg Medical Center.
CDER anticipates providing in FY2012 $250,000 (total costs include direct and indirect costs), for one award subject to availability of funds in support of this project.
Support will be 1 year with the possibility of an additional year of noncompetitive support. Continuation beyond the first year will be based on satisfactory performance during the preceding year, receipt of a noncompeting continuation application and subject to the availability of Fiscal Year appropriations.
To submit a paper application in response to this FOA, applicants should first review the full announcement located at:
• Step 1: Obtain a Dun and Bradstreet (DUNS) Number.
• Step 2: Register With Central Contractor Registration.
• Step 3: Register With Electronic Research Administration (eRA) Commons Steps 1 and 2, in detail, can be found at:
The following references have been placed on display in the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Marckmann, Peter; Skov, Lone; Rossen, Kristian; Dupont, Anders; Damholt, Mette Brimnes; Heaf, James Goya; and Thomsen, Henrik,
2. Wang, Yingbing; Alkasab, Tarik; Narin, Ozden; Nazarian, Rosalynn; Kaewali, Rathachai, Kaewlai; Kay, Jonathan; and Abujudeh, Hani,
3. Prince, Martin; Zhang, Honglei; Zou, Zhitong; Staron, Ronald; and Brill, Paula,