Clarification of Language in the Research Objectives Section and Deletion of Revisions for RFA-DK-10-502: Limited Competition for the Continuation of the NIDDK Gastroparesis Consortium (U01)

Notice Number: NOT-DK-10-004

Key Dates
Release Date:  May 27, 2010

Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www2.niddk.nih.gov/)

The purpose of this Notice is to clarify language in the Research Objectives section and to inform the applicant community that revision applications are not allowed in response to RFA-DK-10-502: Limited Competition for the Continuation of the NIDDK Gastroparesis Consortium (U01).

Paragraph 7 of the Research Objectives section has been clarified. It previously stated:

One objective of this Limited Competition is to provide support to continue following the well-characterized cohort of gastroparetic patients and begin to utilize the NIDDK Repository of stored samples to answer important questions, but not limited to those listed below, such as:

  • What are the phenotypic and genotypic characteristics of Gastroparetic population?
  • Is there correlation with ICC values, along with mucosal and serosal EGG recordings and how do they define the relationship of cutaneous EGG to ICC and ICC to symptoms in GP?
  • Is temporary gastric electrical stimulation effective to reduce vomiting in individuals with drug refractory idiopathic Gastroparesis?
  • What are the molecular correlates of Gastroparesis?
  • What are the mechanisms of abdominal pain as it relates to severity, quality of life, gastric retention, and analgesic vs. prokinetic/antiemetic drug use?

Paragraph 7 now indicates:

One objective of this Limited Competition is to provide support to continue following the well-characterized cohort of patients with gastroparesis recruited by the clinical centers. Furthermore, it is anticipated that the clinical centers will utilize the NIDDK Repository of stored samples to answer important questions, but not limited to those listed below, such as:

  • What are the phenotypic and genotypic characteristics of Gastroparetic population?
  • Is there correlation with ICC values, along with mucosal and serosal EGG recordings and how do they define the relationship of cutaneous EGG to ICC and ICC to symptoms in GP?
  • Is temporary gastric electrical stimulation effective to reduce vomiting in individuals with drug refractory idiopathic Gastroparesis?
  • What are the molecular correlates of Gastroparesis?
  • What are the mechanisms of abdominal pain as it relates to severity, quality of life, gastric retention, and analgesic vs. prokinetic/antiemetic drug use?

NIDDK will not permit Revision applications in response to RFA-DK-10-502.  The following sections within the FOA have been deleted or revised:

Section IV.6.: Other Submission Requirements, PHS 398 Research Plan Section previously stated:

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:

  • Introduction (required for a revision application) is limited to 1 page.
  • Specific Aims is limited to 1 page.
  • Research Strategy, including tables, graphs, figures, diagrams, and charts is limited to 12 pages. See Table of Page Limits.

The Introduction bullet has been deleted and the section now states:

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:

  • Specific Aims is limited to 1 page.
  • Research Strategy, including tables, graphs, figures, diagrams, and charts is limited to 12 pages. See Table of Page Limits.

Section V. Applicant Review Information, Review and Selection Process, Review Process has been revised.  It previously indicated:

Revision Applications.  When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project.  If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

It now states:

Revision Applications.  Revision applications are not permitted in response to this announcement.

All other aspects of this Funding Opportunity Announcement remain unchanged.

Inquiries

Please direct all inquiries regarding this Notice to:

Frank A. Hamilton, M.D., MPH
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 669, MSC 5450
Bethesda, Maryland 20892-54508
(for Express or Courier service use Zip code 20817)
Telephone:  (301) 594-8877
Fax:  (301) 480-8300
Email:  [email protected]