NOT-OD-08-051: Notice of Amendment to the Number of Applications per Applicant Organization and Clarification of Page Limitation for RFA-OD-08-001 “Rare Diseases Clinical Research Consortia (RDCRC) for Rare Diseases Clinical Research Network (U54)”

Notice of Amendment to the Number of Applications per Applicant Organization and Clarification of Page Limitation for RFA-OD-08-001 Rare Diseases Clinical Research Consortia (RDCRC) for Rare Diseases Clinical Research Network (U54)

Notice Number: NOT-OD-08-051

Key Dates
Release Date: March 6, 2008

Issued by
Office of Rare Diseases (ORD), National Institutes of Health (NIH)

Description

1) The Office of Rare Diseases, National Institutes of Health has amended RFA-OD-08-001 (http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-08-001.html), entitled "Rare Diseases Clinical Research Consortia (RDCRC) for the Rare Diseases Clinical Research Network (U54)”, with regard to the total number of applications per organization/ institution that may be submitted. Previously, the RFA indicated that only one application per applicant organization in response to this RFA will be accepted. This restriction has been revised to “More than one application per organization/Institution may be submitted as long as the rare diseases represented in the applications are distinctly different". All other aspects of RFA-OD-08-001 remain unchanged.

2) In addition, ORD gives a Notice of clarification for page limitations for the following components of the application.

Clinical Research Projects for Observational/Longitudinal Studies or Clinical Trials. The page limitation specified applies to the Research Plan only. Section IV. Application and Submission Information, 6. Other Submission requirements, under Clinical Research Projects for Observational/Longitudinal Studies or Clinical Trials, the second and third paragraph should read as:

Title Page with Project Leaders (This title page is not PHS 398 Face Page)
Description: project summary and relevance
Budget/Budget Justification Pages
Research Plan (If an ongoing project, discuss scientific progress within the original 5-year time frame).
Human Subjects Research
Data Safety and Monitoring Plan
Women and Minority Inclusion
Targeted/Planned Enrollment Table (for each clinical research study)
Inclusion Enrollment Report Table (for renewal application)
Inclusion/Exclusion of Children
Literature Cited
Consortium/Contractual Arrangements
Resource Sharing
Consultants/Commercial Agreements

Do not use the PHS 398 Table of Contents. Create your own Table of Contents using the format outlined above. The project should begin with the title of the project, description and budget pages and should follow the instructions for Form PHS 398. Research plan should be limited to 15 pages. Describe the research section in enough detail so the scientific merit can be judged on the basis of the written proposal. Begin each project with a short section that clearly states how that project contributes to the objectives of the RDCRC as a whole.

The budget for each research project should reflect the instructions for Form PHS 398. A detailed budget is required for the first year; budget estimates are required for all subsequent years of support. Explicit and detailed budget justifications must be included for all years. Budget pages must be labeled so that they can be readily associated with the particular projects to which they apply. The project leader should devote at least 1.8 calendar months to the research. In the project, include the section for human subjects and carefully follow the detailed instructions the PHS 398 guidelines.

Under Section IV. Application and Submission Information, 6. Other Submission Requirements, the page limitation specified for the following three components of the application applies to Plans/Examples only.

Pilot/Demonstration Project Program (PPP). The page limitation should read as: The presentation of Plan/Examples should be limited to 10 pages.

Training (Career Development) Component. The page limitation should read as: The presentation of Plan/Examples should be limited to 5 pages.

Administrative Unit. The page limitation should read as: The presentation of Plan/Examples should be limited to 5 pages.

The remaining information contained in Section IV. Application and Submission Information is retained as published in the original announcement.

The full text of the RFA, which was published on February 8, 2008, can be accessed at http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-08-001.html.

Inquiries

For further information regarding this Notice, please contact:

Rashmi Gopal-Srivastava, Ph.D.
Office of Rare Diseases
National Institutes of Health
6100 Executive Blvd., Suite 3B01, MSC 7518
Bethesda, MD 20892-7518
Phone: 301 402 4336; Fax 301 480 9655
Email: [email protected] (e-mail is the strongly preferred method for inquiries)