Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) ( www.nih.gov)

Components of Participating Organizations
This FOA is developed as a Roadmap initiative. All NIH Institutes and Centers participate in Roadmap initiatives. This FOA will be administered by the National Human Genome Research Institute on behalf of the NIH. http://www.genome.gov

Title: A Data Analysis & Coordination Center (DACC) for the Human Microbiome Project (U01)

Announcement Type
New

Request for Applications (RFA) Number: RFA-RM-08-007

Catalog of Federal Domestic Assistance Number(s)
93.310

Key Dates
Release Date:  December 12, 2007
Applicant information meeting: December 10, 2007 (see http://www.scgcorp.com/MicrobiomeAppIic/)
Letters of Intent Receipt Date: January 15, 2008
Application Receipt Date: February 15, 2008  
Peer Review Date(s): June/July, 2008
Council Review Date: August 2008
Earliest Anticipated Start Date: September 30, 2008
Additional Information To Be Available Date (URL Activation Date): N/A
Expiration Date: February 16, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

Section II. Award Information
  1. Mechanism(s) of Support
  2. Funds Available

Section III. Eligibility Information
  1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
  2.Cost Sharing or Matching
  3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
  1. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements  
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. NIH Responsibilities
      3. Collaborative Responsibilities
      4. Arbitration Process
  3. Reporting

Section VII. Agency Contact(s)
  1. Scientific/Research Contact(s)
  2. Peer Review Contact(s)
  3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The purpose of this FOA is to solicit applications for a Cooperative Agreement (U01) award to develop and implement a Data Analysis and Coordination Center (DACC) as part of the of Human Microbiome Project (HMP.  See http://nihroadmap.nih.gov/hmp/). The overall goals of the DACC are to provide a portal for data access to the various types of data and tools generated by several federally funded HMP initiatives, to coordinate development of data and metadata standards and coordinate deposition of those data from the various HMP groups to the appropriate public repositories (in some cases the DACC itself), and to provide a certain level of data analysis both in its role as coordinator of all data generated and as a service to the various HMP projects as needed.

Background

The complex and dynamic communities of microbes (the human microbiota) that are present on and within the human body are thought to profoundly influence human physiology, nutrition, immunity and development.  Accordingly, alterations in community structure and dynamics may reflect, or trigger, disease states.  Studies on humans and vertebrate animal models have uncovered strong evidence that this is the case for some specific diseases.  However, the range and magnitude of microbiome effects upon health and disease are not known.  Initiation of the Roadmap 1.5 Human Microbiome Project is an expansion of the effort to understand the human microbiome, starting with the identification, quantification, and analysis of the microbial populations of which it is composed, particularly as these change with the health status of the individual.

The NIH Roadmap program is a trans-NIH effort to accelerate the discovery and translation of scientific knowledge into public health benefits. The Roadmap program is designed to provide a five to ten-year “incubator space” for new NIH initiatives that promise to transform biomedical research, address the missions of a number of the NIH Institutes, and provide a public health benefit by having the data available in the public domain.   The NIH Roadmap began in 2004 with an initial set of efforts (http://nihroadmap.nih.gov).  This year, a second round of Roadmap projects was chosen following a public nomination and NIH review process.  The Human Microbiome Project (HMP) was chosen as one of these, to start in 2007/2008.  The goal of the HMP is to extensively characterize the human microbiome and create a technological and data research resource that will enable in-depth study of its variation (with e.g., population, genotype, disease, age, nutrition, medication and environment) and its influence on health and disease.  It is anticipated that exploration of this new and different approach to human health will provide insights that will enable the development of new approaches to monitoring health status, improved understanding of the etiology of disease, and development of new therapeutic and preventive strategies, through the maintainance or re-establishment of a healthy microbiota.

The HMP is being implemented in a phased manner (See http://nihroadmap.nih.gov/hmp/).  Briefly, the HMP has been designed as a five-year effort with several components:  (1) generation of a reference set of genome sequences from isolated members of the microbial communities at different anatomical sites on the human body; (2) initial metagenomic studies that will generate an initial estimate of the complexity of themicrobial community at each site, provide initial answers to the questions of whether there is a “core” microbiome at each site and whether variation in the microbiome can be systematically studied; (3) demonstration projects to determine whether variation in the microbiome at a site can be related to human phenotypes, such as disease; (4) development of new technologies, informatics capabilities and resources that are needed for the development of the field of metagenomics; and (5) analysis of potential ethical, legal, and social issues (ELSI) that will need to be considered in the study and application of the metagenomic analysis of the human microbiota The purpose of this announcement is to solicit applications to support the informatics aspects of the fourth of these components (#4).

Objectives of this Research Program

Applications are being sought to establish an HMP Data Analysis and Coordination Center (DACC) for the Human Microbiome Roadmap Program. The DACC will be an informatics resource where information about the project, as well as results and conclusions, will be available to the scientific community. More specifically, the DACC will manage data and metadata, if necessary store data and metadata, facilitate analysis of data and utilization of tools from HMP funded projects and may also incorporate information from other relevant resources as needed. The efforts of the DACC should be focused on collecting, tracking, and distributing relevant data and information from and for the HMP but should not duplicate informatics efforts of other funded projects. However, it will be important for the DACC to have close interactions with the other HMP informatics efforts to facilitate the transfer, exchange and dissemination of information.

Overview of the DACC responsibilities:

Research Scope

The DACC will manage and, where appropriate, store both raw and processed data generated from the multiple experimental and computational methods that will be used by HMP participants. Experimental approaches will include, but will not be not limited to, molecular characterization technologies such as whole genome and metagenomic shotgun sequencing, 16S rRNA gene sequencing, high throughput gene expression analysis and possibly proteomic analytic techniques. Sequence, assembly and reference genome annotation data will be stored in available public databases such as those supported through the National Center for Biotechnology Information (NCBI), e.g., the Trace Archive and the newly developed Short Read Archive (SRA) which will handle data generated by new sequencing technologies.  Raw data from gene expression, proteomics,16SRNA or clinical phenotype data is also anticipated to be stored in public databases such as Gene Expression Omnibus (GEO), Entrez Protein, UniProt or the database for Genotype and Phenotype (dbGaP). These examples are illustrative and should not be considered to be exhaustive in any way nor should it be expected that these data would necessarily be generated by the HMP itself.

The DACC will be required to support the tracking of raw data submitted to public databases and compile and track data being generated by the different HMP projects. In addition, relevant metadata that describes the experimental, computational and clinical methods and protocols, as well as phenotypes will also need to be managed, and if necessary, stored by the DACC. Coordinating the development of metadata standards will also be the responsibility of the DACC. The DACC should be able to capture links to raw data in public repositories and to metadata describing experimental or informatics methods. The DACC will implement quality assurance methods to ensure that data meet the relevant data formats for submission to public databases or storage within the DACC.

The following types of processed data may be generated and will need to be linked to the genomic sequence and stored at the DACC: data that identify genomic signatures by phylogenetic inference, gene finding data and comparative genomic and proteomic data. The DACC may also be required by NIH to identify and import data from research projects outside the HMP that generate data related to the goals of the HMP. It is unclear what all the data types that will be produced by the funded HMP project will be as the proposals for funding these projects will be reviewed in parallel with the applications to this FOA. However, it is anticipated that research funded through other HMP FOAs will generate several raw and processed data types from different experimental approaches. It is expected that these data will be stored in public databases or the DACC, whichever is the most appropriate. All sources of metagenomics data stored in the DACC should be identified and have links back to the original sources.  The DACC should be able to adapt to additions and changes in data types for the duration of the HMP.

The DACC will work with the members of the HMP or any analysis groups sponsored by HMP to facilitate analysis of the metagenomic data. Should defined freezes of metagenomic data be required, the DACC will help implement them and ensure that these data meet informatics quality control standards.

The DACC should use robust and flexible data management and retrieval tools capable of handling all of the metagenomic data that will be stored. Where possible, the DACC should use existing software.  The utilization and, where appropriate, extension or creation of new open source software is encouraged. The DACC is expected to be able to work with the funded projects within the HMP to establish the exact data types and formats that will be transferred to the DACC along with developing procedures to check and track the quality of incoming data.

The DACC will provide efficient and unencumbered access to HMP data and tools maintained within the DACC. The DACC should provide multiple mechanisms for accessing metagenomic data and tools. These include methods to analyze and retrieve data as well as for data visualization.  Some examples include; multiple sequence alignment views, use of a genome browser and gene ontology or phylogeny trees. These examples are illustrative and should not be considered limiting in any way. Methods for freely and easily downloading large data sets from the DACC, so that users can acquire and analyze all or large parts of the data, should also be provided. The DACC should provide the data in formats that will facilitate additional analysis by members of HMP and by the broader scientific community. The DACC should establish a portal that provides information about the HMP Project to the broader scientific community and to coordinate information for the International Human Microbiome Consortium.

The DACC applicant should propose plans to:

Implement the goals of the overall DACC project as described above.

Propose metrics and timelines that the applicant will use to evaluate progress based on information about the overall HMP found at (http://nihroadmap.nih.gov/hmp/) and the published HMP FOAs.  These goals should include, but are not limited to, any planned software or database development and implementation activities, the anticipated level of throughput for capturing and processing data from the funded projects of the HMP, the anticipated number of data freezes and data releases during the project period and the development of a web portal that provides clear and easy access to data and tools from the HMP and is accessible to the general scientific community. Milestones may be revised at the time of the award as described in the terms and conditions of a Cooperative Agreement in Section 2.A.2.

Work with data and tools from the variety of different experimental and computational projects that are expected to be funded through companion HMP FOAs: Construction of a Reference Sequence Data Set for the HMP (RFA RM-08-001) and Human Microbiome Demonstration Projects (RFA RM-08-012).  Other types of data and bioinformatics tools may be generated through other HMP FOAs calling for development of new technologies needed for studying the human microbiome and development of new tools for computational analysis of HMP data. Those FOAs will be published and reviewed on approximately the same timeline as this FOA and therefore the types of data and tools to be generated are not yet known.  Furthermore, the outcome of the research supported by those programs will not be clear for several years after funding.  Therefore, applicants for this FOA should also indicate how they would incorporate new data types or tools that become available over the duration of the grants.

Work with members of the HMP, any analysis groups sponsored by HMP and the scientific research community to facilitate analysis of the metagenomic data.

Use existing or justify development of new data management tools to handle the data and tools generated by the HMP projects. Details about development of data and metadata formats and efficient data delivery systems need to be discussed.

Provide training, documentation and technical support for end users. These plans should recognize the different types and experience of users of the DACC. Users will be both participants of the HMP and outside users from the broader scientific community. Users will have different levels of sophistication in the use of metagenomic data and informatics tools. Any training plan should accommodate these different levels of experience.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the UO1 Research Project Cooperative Agreement award mechanism.

The NIH U01 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award". Plans for support of the funded grants beyond the five-year Roadmap funding are indefinite.  It is anticipated that the goals of this FOA will be completed (or exceeded) during the term of the project.

2. Funds Available
 
The total costs available for this award is approximately $2 million dollars for each of 5 years to fund one new cooperative agreement in response to this FOA.  An applicant may request a project period of up to 5 years.  The anticipated award date is September 2008.

Although the financial plans of the NIH provides support for this program, awards by the IC pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
 
2. Cost Sharing or Matching

Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Items 2-5 of the PHS398 Research Plan component are limited to 25 pages.

Applications Involving Federal Agencies

The requests from federal agencies, including the NIH intramural program, will not include any salary and related fringe benefits for career, career conditional or other federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative costs).

In general, the budget requests will be limited to the incremental costs required for carrying out the proposed work.  These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. While support for extramural collaborators may be requested in a separate grant application, funds can be requested for services by an external investigator or contractor as a subcontract/consortium including the applicable indirect (F&A costs) of the contractor/collaborating institution.

Justification must be provided for all requested support and for the Federal employees who will be committed to the project although no funds are requested in the application.

Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Applicant information meeting: December 10, 2007 (see http://www.scgcorp.com/MicrobiomeAppIic/)
Letters of Intent Receipt Date: January 15, 2008
Application Receipt Date: February 15, 2008  
Peer Review Date(s): June/July, 2008
Council Review Date: August 2008
Earliest Anticipated Start Date: September 30, 2008

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to the following or by email to the address listed.  These letters will be directed to the HMP working group member (http://nihroadmap.nih.gov/hmp/members.asp) representing the NIH Institute/center most appropriate for the health condition/disease proposed for study.   Applicants may contact any of the HMP working group members listed at http://nihroadmap.nih.gov/hmp/members.asp. 

Vivien Bonazzi, PhD
Program Director, Genome Informatics
Division of Extramural Research
National Human Genome Research Institute
5635 Fishers Lane, Suite 4076, MSC 9305
Bethesda, MD 20892-9305 (U.S Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 496-7531
Email: bonazziv@mail.nih.gov  or hmprfainformation@mail.nih.gov

3.B. Sending an Application to the NIH
 
Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
 
Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NHGRI and HMP Implementation group members. Incomplete and non-responsive applications will not be reviewed and will be returned.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

“Authorization and Consent".

The government may, at its discretion, provide its Authorization and Consent and/or Indemnity to the grantee at the time of the award.

(a) The Government authorizes and consents to all use and manufacture of any invention described in and covered by a United States patent in the performance of this Cooperative Agreement.

Notice and Assistance Regarding Patent and Copyright Infringement.

(a) The Grantee shall report to the Program Director, promptly and in reasonable written detail, each notice or claim of patent or copyright infringement based on the performance of this Cooperative Agreement of which the Grantee has knowledge.

(b) In the event of any claim or suit against the Government on account of any alleged patent or copyright infringement arising out of the performance of this Cooperative Agreement or out of the use of any supplies furnished or work or services performed under this Cooperative Agreement, the Grantee shall furnish to the Government, when requested by the Program Director, all evidence and information in possession of the Grantee pertaining to such suit or claim. Such evidence and information shall be furnished at the expense of the Government except where the Grantee has agreed to indemnify the Government.

(c) The Grantee agrees to include, and require inclusion of, this clause in all subawards and subcontracts at any tier for supplies or services (including construction and architect-engineer subawards and subcontracts and those for material, supplies, models, samples, or design or testing services).

Patent Indemnity.

(a) The Grantee shall indemnify the Government and its officers, agents, and employees against liability, including costs, for infringement of any United States patent (except a patent issued upon an application that is now or may hereafter be withheld from issue pursuant to a Secrecy Order under 35 U.S.C. 181) arising out of the manufacture or delivery of supplies or materials or the performance of services under this Cooperative Agreement, or out of the use or disposal by or for the account of the Government of such supplies or materials.

(b) This indemnity shall not apply unless the Grantee shall have been informed as soon as practicable by the Government of the suit or action alleging such infringement and shall have been given such opportunity as is afforded by applicable laws, rules, or regulations to participate in its defense. Further, this indemnity shall not apply to

(1) An infringement resulting from compliance with specific written instructions of the Program Director;

(2) An infringement resulting from addition to or change in supplies or components furnished or construction work performed that was made subsequent to delivery or performance; or

(3) A claimed infringement that is unreasonably settled without the consent of the Grantee, unless required by final decree of a court of competent jurisdiction.”

Intellectual property management plan

A primary objective for the Human Microbiome Project is to maximize the public benefit of the data produced. Accordingly, awardees should manage intellectual property (IP) and data in a way that achieves this goal. In the case of the HMP, awardees are expected to generate a large collection of data that will serve as a foundation for the scientific community to develop future diagnostics, therapeutics and other medical applications. To achieve the objective of producing and broadly sharing the resources generated by the HMP, applicants should develop a comprehensive IP and data management strategy that is consistent with the NIH Research Tools Policy (http://ott.od.nih.gov/policy/research_tool.html). Examples which applicants may wish to consider include the recommendations cited in NIH’s Best Practices for the Licensing of Genomic Inventions (http://www.ott.nih.gov/policy/genomic_invention.html).

It is intended that the tools of scientific discovery necessary to rapidly and effectively develop new diagnostics, therapeutics and other medical applications be widely available for research use. Accordingly, awardees will be expected to manage IP in a way that is consistent with the goals of the initiative and in accordance with applicable NIH guidelines and best practices. Applicants should submit an IP Management Plan that assures that data is rapidly released according to approved criteria (see above), that licensing and sharing practices ensure the availability of data and research resources for future use by the scientific community, and that research collaboration or sponsorship agreements are consistent with the requirements of the HMP. IP Management Plans, once approved, will also become Terms and Conditions of award.

Restrictive licensing and sharing practices for HMP data could substantially diminish the value and public benefit provided by this community resource project. Management practices that would prevent or block access to, or use of HMP data and resources for research use will be considered to be hindering the goals of the HMP Initiative. Applicants are encouraged to clearly demonstrate in their IP Management plan how their strategies will achieve the desired public benefit and programmatic goals through effective sharing of HMP data and tools.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Applicants should discuss the following:

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

This award will entail specific terms and conditions appropriate to the U01 mechanism and the structuring of the HMP program as a research network. See Section VI below.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Center for Scientific Review (CSR) in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is there a high likelihood that the proposed effort can produce a high-quality metagenomic data and analysis coordination center, based on the applicant’s past experience and the proposed future plans, to demonstrate the impact of changes in the microbiome to human health and disease?

Approach: Is the computational framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: does the project challenge existing paradigms for data management and address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed.  See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R)
 
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the adequacy of the plans for their care and use will be assessed. See the “Other Research Plan Sections” of the PHS398 Research Plan component of the SF424 (R&R). 

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers.  Adequacy of the data release plan will be considered in the review and in making funding decisions, and may be negotiated by program staff prior to making an award.  The presence of a data sharing plan will be part of the terms and conditions of the award.  The funding organization will be responsible for monitoring the data sharing policy.   

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Award Administration Information, “Reporting.”

3. Anticipated Announcement and Award Dates

N/A

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.
 
2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement NIH U01, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for defining the details of the HMP DACC within the guidelines of this FOA and for performing the scientific activities. The P.I. will agree to accept close coordination, cooperation, and participation of NIH HMP Program staff in those aspects of scientific and technical management of the project as described under "NIH Program Staff Responsibilities."

The P.I. of the Data Analysis and Coordination Center (DACC) for the HMP project will:

Committee, External Consultants Panel, the NHGRI and the NIH HMP working group .


 2.A.2. NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

An NIH HMP Project Scientist will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination.  However, the role of NIH HMP Project Scientist will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus of the Human Microbiome Research Network and NIH HMP Project staff will be given the opportunity to offer input to this process. 

One NIH HMP Project Scientist from the Institute that administers the project funded through this FOA shall participate as a member of the Steering Committee and will have one vote.

The Project Scientist will:

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program director may also serve as the NIH Project Scientist.  

2.A.3. Collaborative Responsibilities

A Steering Committee will serve as the main governing board of the Human Microbiome Research Network.   The Steering Committee membership will include NIH HMP Project Scientists and the P.I. of each awarded cooperative agreement.  The Steering Committee Chair will not be an NIH staff member. Additional members may be added by action of the Steering Committee. Other government staff may attend the Steering Committee meetings, if their expertise is required for specific discussions. The Steering Committee will:

Each full member will have one vote.  Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.4. External Scientific Consultants

The External Scientific Consultants (ESC) will be responsible for reviewing and evaluating the progress of the members of the Human Microbiome Research Network toward meeting their individual and collective goals. The ESC will provide recommendations to the Directors, NHGRI, NIAID, NIDCR, NIDDK and the NIH Roadmap Office about continued support of the components of the Human Microbiome Research Network. The Advisory Panel is composed of four to six senior scientists with relevant expertise who are not P.I.s of a cooperative agreement involved in the Human Microbiome Research Network. The membership of the External Scientific Consultants may be enlarged permanently, or on an ad hoc basis, as needed. 

The External Scientific Consultants will meet at least once a year. During part of this meeting, there will be a joint meeting with the Steering Committee to allow the External Scientific Consultants members to interact directly with the awardees. Annually, the External Scientific Consultants will make recommendations regarding progress of the HMP and present advice about changes, if any, which may be necessary in the HMP to the Directors, NHGRI, NIAID, NIDCR, NIDDK and NIH Roadmap Office.

2.A.5. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually ( http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Awardees will also be required to submit periodic (quarterly) progress reports in a standard format, as agreed upon by the Steering Committee and the ESC. As part of good program management, the NIH may request information essential to an assessment of the effectiveness of this Program. Accordingly, recipients are hereby notified that grantees may be asked to provide information for program evaluation purposes, both locally and at the national level.

Each awardee will be asked to define a set of yearly milestones for the U01 at the time of the award and to update these milestones annually at the anniversary date. These will be made a condition of the award.  In accord with the procedures described above, NIH may withhold or reduce funds for a project that substantially fails to meet its milestones or to maintain the state of the art.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:
 
Vivien Bonazzi, PhD
Program Director, Genome Informatics
Division of Extramural Research
National Human Genome Research Institute
5635 Fishers Lane, Suite 4076, MSC 9305
Bethesda, MD 20892-9305 (U.S Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 496-7531
Email: bonazziv@mail.nih.gov  or hmprfainformation@mail.nih.gov

2. Peer Review Contacts:

Dr. Alexander Politis
Infectious Diseases and Microbiology IRG
Center for Scientific Review

MSC 7808
6701 Rockledge Dr
Bethesda, MD 20892-7808

Telephone: (301) 435-1150
FAX:  (301) 480-0940
Email: politisa@csr.nih.gov

3. Financial or Grants Management Contacts:
 
Ms. Cheryl Chick
Division Of Extramural Research
National Human Genome Research Institute
Room number 4061
5635 Fishers Ln
Bethesda, MD 20892
Telephone: (301) 435-7858

Section VIII. Other Information


Required Federal Citations
 
Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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