Notice Number: NOT-RM-10-006

Key Dates
Release Date:  March 19, 2010

Issued by
National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov/)

Purpose

The purpose of this Notice is to modify the language of RFA-RM-09-019 with regard to Section IV. Application and Submission Information: Part 2. Content and Form of Application Submission; Format of the Application; Item F. Institutional Clinical and Translational Science Award Program, and to correct the total number of pages in the Executive Summary: Application Research Plan Component and Length.

In RFA-RM-09-019, Item F of the Format of the Application section currently reads:

F. Institutional Clinical and Translational Science Award Program: The application must present all the proposed activities of the CTSA within the page limits shown above. Note that these are upper limits: applicants are urged to be concise and to present information in tables where possible. According to NIH policy, applicants should not provide programmatic URL's in their applications. No appendices are allowed. References are not included in the page limits and may be cited in the appropriate sections of the application. The information should be arranged as described above. Note that the additional 50 permitted pages of Tables or Figures may be sited in the text so as best to facilitate review.

Item F is now modified to read:

F. Institutional Clinical and Translational Science Award Program: The application must present all the proposed activities of the CTSA within the page limits shown below. Note that these are upper limits: applicants are urged to be concise and to present information in tables where possible. According to NIH policy, applicants should not provide programmatic URL's in their applications. No appendices are allowed. Note that the additional 50 permitted pages of Tables or Figures may be sited in the text so as best to facilitate review. References are not included in the page limits and may be cited in the appropriate sections of the application or in Section G. The information should be arranged as follows:

(1)  Overall Impact: Prior Funding Period: Performance that includes an assessment of the local and consortium-wide impact of the CTSA in the prior project period. This section may include 20 pages of text and 20 pages of tables, 40 pages total.
(2) Approach (25 pages plus 5 pages of Tables).
(3) Governance (25 pages) to include the following sub-headings. Multi-PI applications must preface these with a leadership plan and have a page limit of 30 pages.

• approach --meeting the intent of this initiative
  
• participating institution(s)
  
• innovation
  
• institutional commitment
  
• governance
  
• national collaboration, sharing, and dissemination plan
  Note: this section should include a description of resources and environment, replacing the corresponding page in PHS 398.

(4) Up to 15 pages for each selected key functions, except as shown

• biomedical informatics
  
• research education, training and career development (25 pages). Up to 20 additional pages may be used to describe the educational tracking and evaluation plan.
  
• community engagement and research
  
• evaluation of CTSA
  
• pilot translational and clinical studies
  
• regulatory knowledge and support
  
• development of novel clinical and translational methodologies
  
• research design, biostatistics and clinical research ethics
  
• clinical research resources and facilities
  
• translational technologies and resources
  
• milestones and implementation plans (5 pages)
  
• other program functions (up to 15 pages per function; 50 pages total)

(5) Other Tables (50 pages maximum). The organization and content of the tables are left up to the applicant; however, summary and graphical displays are encouraged. Organization tables can be distributed throughout the application in proximity to their respective sections..

RFA-RM-09-019 Executive Summary currently states:

Application Research Plan Component and Length. The U54 application Research Plan component of the PHS 398 may not exceed 335 pages, including tables, graphs, figures, diagrams, and charts.

This is now modified to read:

Application Research Plan Component and Length. The U54 application Research Plan component of the PHS 398 may not exceed 385 pages, including tables, graphs, figures, diagrams, and charts.

All other aspects of this FOA remain unchanged.

Inquiries

We encourage your inquiries concerning this Notice and welcome the opportunity to answer questions from potential applicants:

Dr. Anthony Hayward
Division for Clinical Research Resources, NCRR
6701 Democracy Boulevard
Room 906, MSC 4874
Bethesda, MD 20892
Telephone: (301) 435-0790
Fax: (301) 480-3661
Email: haywarda@mail.nih.gov

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.