Notice Number: NOT-RM-08-015

Key Dates
Release Date: April 11, 2008

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

Purpose

The purpose of this notice is to inform the community of: 1) change in the receipt date for letters of intent; 2) change in the application receipt date; and 3) clarifications in Sections   of the Funding Opportunity Announcement RFA-RM-08-012: Human Microbiome Demonstration Projects (UH2/UH3) http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-08-012.html. 

The receipt dates of the following have been changed:

• Letters of Intent are due by May 24, 2008.  Prospective applicants who have already submitted a letter of intent do not need to submit another letter of intent.
  
  
• Applications are due by June 24, 2008.

The following clarifications have been made to the following sections in Part II.  The bold language indicates where the changes have been made:

1.  The Executive Summary:

The 2nd bullet should read:

• Mechanism of Support. This FOA will use the UH2/UH3 cooperative agreement mechanisms to support the demonstration project awards.  The program will be funded in two phases, as allowed by this mechanism.  The initial pilot phase (UH2) will allow investigators to procure samples and generate data that will be used to support the scale-up phase (UH3), which will be awarded after administrative review to those projects that have the most promise to demonstrate whether or not the human microbiome plays an important role in human health and disease.  UH2 projects that have made substantial progress toward the goals/milestones set out for the  first year of the UH2, but are not deemed ready to be scaled up by this administrative review, will be considered on a case by case basis for continued funding for one, two or three additional years. 

The 3rd bullet should read:

• Funds Available and Anticipated Number of Awards. The total amount of funds available for these awards is approximately $4 million total costs for the UH2 in FY 09 and $24.3 million for the UH2/UH3s in FY 10-12. Up to 10 UH2 and 5 UH3 awards are anticipated from this solicitation. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

2.  Part II, Section I.1, Objective 2, Paragraph 3 should read:

It should be noted that the budget for the three years of the UH3 phase of the initiative (see below) or for the continued UH2 phase will decrease by 10% per year because NIH expects that the cost of data production will drop significantly in each year of the program.  The applicant should address how data production costs will be reduced to accommodate this reduction during the grant period.   If new technologies, particularly sequencing technologies, are to be utilized, the applicant’s track record in using the technologies must be provided; this will be an important review criterion.

3.  Part II, Section I.1, Objective 3, Paragraph 4 should read:

At the end of the first year of the UH2 awards, there will be an administrative review to determine which of the cooperative agreements will transition to the UH3 phase and which of the UH2 awards should continue to be supported at the pilot level.  The administrative review will be conducted by the Roadmap HMP staff, outside experts and NIH Advisory Councils, who will consider several factors, including both the progress made toward and potential for achieving the goals of the program, i.e. whether the chosen system will demonstrate how changes in the microbiome relate to human health.  Beyond attaining or exceeding the stated first-year milestones, the successful projects will be those that are judged to have the potential to make the most significant impact on understanding the relationship between the human microbiome and human health.  Other factors that will be considered include significance of the health problem being addressed and program balance.  Thus, along with milestones, applicants should propose, where possible, other approaches to determining progress and significance. 

4.  Part II, Section II.2, Paragraph 2 should read:

The NIH intends to commit approximately $28.3 million dollars total costs to this initiative over its term of fiscal year 2009-12. Up to 10 UH2 pilot awards will be made and up to 5 UH3 scaled up projects will be awarded following administrative review of the results from the first year of the pilot phase. The anticipated start date of the pilot phase is April 2009. The expected amount of each UH2 award is $300,000 to $700,000 (direct costs) and the expected amount of each UH3 award is $1 million to $3 million (direct costs), depending upon the number of awards made. As noted above, UH2 awards that continue beyond the first year will be funded each additional year at a level 10% less than the previous year. Through Roadmap funding, approximately $4 million in FY 2009, $8.7 million in FY 2010, $8.1 million in FY 2011 and $7.5 million in FY 2012 will be available for applications funded under this FOA.

5.  Part II, Section II.2, Paragraph 3 should read:

An applicant may request a project period of up to 4 years and a budget for direct costs up to $700,000 (direct costs) for the UH2 and $3 million (direct costs) per year for the UH3.

6.  Part II, Section IV.6.IV.2, Paragraph 1 should read:

The applicant should present a clear plan, including concrete milestones, for producing data that will be used to address the goals laid out above.  Milestones are needed for each quarter of the pilot project year (UH2) and yearly for years 2 through 4.  Applicants that receive a continuation of a UH2 award after year 1 will be asked for revised milestones at that time.  The milestones requested for the current application include, for all technologies:

7.  Part II, Section VI.2.A.1, The 7th bullet should read:

• Submit quarterly progress reports during the first year pilot phase, in a format as agreed upon by the Steering Committee and the ESC.  Projects that are selected for continued support through either the UH2 or UH3 mechanism will submit progress reports on a regular basis, at least biannually;  

All other aspects of the RFA remain unchanged. The full text of the RFA, which was published on December 4, 2007, can be found at: http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-08-012.html.

This Notice is effective immediately.

Inquiries

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.  The scientific contact for this Notice and the Request for Applications is:

Jane L. Peterson, Ph.D. for the Human Microbiome Working Group (http://nihroadmap.nih.gov/hmp/members.asp)
Division of Extramural Research
National Human Genome Research Institute
5635 Fishers Lane
Room Number 4076
Bethesda, MD 20892
Telephone: (301) 496-7531
FAX:  (301) 480-2770
Email: hmprfainformation@mail.nih.gov

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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)
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