Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Human Genome Research Institute (NHGRI)

Funding Opportunity Title

Genomic Resource Grants for Community Resource Projects (U41)

Activity Code

U41 Biotechnology Resource Cooperative Agreements

Announcement Type

New

Related Notices
Funding Opportunity Announcement (FOA) Number

PAR-11-095

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic
Assistance (CFDA) Number(s)

 93.172   

FOA Purpose

Genomic research has had substantial impact on biomedical research, in large part because of the open sharing of data (often prior to publication) and resources with the greater research community.  To facilitate genomic research and the dissemination of its products, NHGRI supports resources that are crucial for disease studies, model organism studies, and other biomedical research.  This FOA encourages applications for the development and support of genomic resources that will be available to and valuable for the broad research community.  Such resources include (but are not limited to) informatics resources such as model organism databases and ontologies, comprehensive collections of genomic features (such as structural variants), and collections of physical resources (such as samples and cDNA clone banks).

Key Dates
Posted Date
Open Date (Earliest Submission Date)

February 15, 2011

Letter of Intent Due Date

The first letter of intent due date will be February 15, 2011; then letters of intent will be due one month prior to regular receipt dates.

Application Due Date(s)

The first receipt date will be March 15, 2011; then Standard dates apply: May 25, 2011; September 25, 2011; January 25, 2012; May 25, 2012; September 25, 2012; January 25, 2013; May 25, 2013; and September 25, 2013

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

January 8, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

Genomics has had substantial impact on biomedical research, in large part because of the open sharing of data (often prior to publication) and resources with the greater research community.  The widespread availability of genomics resources provides the entire community with comprehensive sets of data and materials of defined and uniform high quality, allows researchers to compare methods and results with the same sets of samples or reagents, allows the integration of multiple data types through use of the same sets of samples or other resources, and promotes the efficient use of funds by not supporting redundant efforts. 

NHGRI currently supports a number of genomics resources.  Examples include model organism databases (MODs), the Genome Ontology (GO), a universal clone resource for Drosophila proteomics, collections of structural variants, and the HapMap sample collection.  The resource projects that NHGRI has funded share several key characteristics:

1.  They fill a demonstrable need and have a wide impact, well beyond the field of genomics itself.

2.  They are comprehensive in scope, covering, for example, the entire genome or all genes of an organism.

3.  They make data or materials broadly available to all researchers in a user-friendly manner.

4.  They use established, state-of-the-art, and robust production methods to generate and distribute high-quality products of lasting value.

5.  They are unique, and do not duplicate resources that are otherwise available.

Scope

This FOA encourages applications for the support of genomic resource projects, either for the continued support of genomic resources of value to the research community or for the development of new ones.  A major goal of this FOA is to provide broad access of these genomic resources to the research community.  This will require awardees to actively disseminate the data and resources supported under these awards.

Resources for which applications will be accepted under this FOA include (but are not limited to):

Awards for support of resources differ from typical research grants.  Many genomic resources, such as databases, fulfill an ongoing community need and support must be provided as long as that need exists and remains a priority to the community.  This means that NHGRI is able to support only a limited number of resources, and that the long-term effects of funding a new resource must be carefully considered.  Many of the awards made under this FOA will be for continued support of existing resources that continue to have value across the entire biological and biomedical research community.  Note that NHGRI’s interest is to meet the community needs, not necessarily to continue support for a specific resource; thus proposals from new providers to meet current needs are welcome.  Applications proposing to develop new databases, repositories, or other resources should clearly explain why there is a need or why the current resources are not adequate. 

All applications should include well-defined milestones and goals that describe what will be accomplished during the award period.  Applications should also include plans for distributing the relevant data or physical resources, and plans for maintenance and distribution of the resource beyond the period of the current award.  Such plans should acknowledge that, at the end of the project period, all data or resources generated by the project must be transferred to NIH or NIH-approved institutions if they were not already placed in lasting databases or repositories accessible to the broad scientific community.  All software must be made freely available to the broad scientific community.

As the choice of which resources to support will be determined in large part by NHGRI-defined programmatic needs, all applicants are strongly encouraged, in the early planning stages of applications, to contact the relevant program officers, who can provide advice about how the proposed resources address programmatic priorities.  

To ensure that the awards continue to meet programmatic needs, NHGRI will use the U41 cooperative agreement mechanism for support of resources.  Under this mechanism, program staff will have significant programmatic involvement in the form of assistance and guidance, although the awardees will have primary responsibility for designing the project and doing the work.  Program staff will monitor progress on achieving the aims, particularly how well the resource is meeting the community need that it was created for.  Program staff will also participate in any modification of the aims as technologies and scientific needs change.  Importantly, program staff will assist the coordination of the work with related resources and research projects.

Other guidance may apply to some, but not all, types of resource applications:

The resources that NHGRI will support must represent work in genomics that is broadly applicable to many diseases and research questions.  If appropriate, applications may include plans for obtaining additional support (co-funding) for the resource.  Applications for resources that support only particular diseases or other specific biological issues should be directed to the appropriate Institute or Center.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Renewal
Resubmission
Revision
The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications..

Award Budget

Application budgets are not limited, but should reflect the needs of the proposed project.

Award Project Period

Applications may request project periods of up to 5 years.  The duration must be justified by the proposed work.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Foreign (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.  Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent (e-mail preferred) should be sent to:

Dr. Vivien Bonazzi
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

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three 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)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Dr. Ken Nakamura
Co-Director, Scientific Review Branch
National Human Genome Research Institute
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892-9305 (for US Postal Service)
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 402-0838
Fax: (301) 435-1580
Email: kn24c@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide must be followed, with the following exceptions or additional requirements:

 
Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Specific Requirements and Research Objectives

The sections listed below are all part of the 30 pages of the Research Strategy.

Overview (required)

The narrative portion of the application should begin with an overview that addresses the following:  the rationale for the community resource, a description of the resource to be generated, community support for the proposed resource, and the anticipated impact of the resource widely across biomedical research.  The overview should also include the project's components, including the core technology(ies) that will be used to generate the resource.   The overview should include preliminary data that support the technological approach, if appropriate.  In renewal applications, the overview should also include a progress report.

Research resource production (required)

The central focus of the project should be the generation of a research resource using established, state-of-the-art technologies.  This section should describe in detail the specific aims, production methods, expected outputs, metrics for production and quality control, quarterly milestones for each component of the production activity, and facilities available to conduct the project.  The investigators who will be responsible for each sub-project should be indicated and their roles described. 

Access and Dissemination (required)

The access and dissemination activities will vary according to the size and goals of the project.  Applicants should include a well-described plan for access to and dissemination of the resource and its contents, consistent with achieving the goals of this program.  For some projects, the reagents or data can be provided to established resources for distribution.  For example, clone sets can be supplied to the appropriate model organism resource centers or commercial distributors, and structural variation data can be provided to the central genetic variation databases.  Some projects, such as MODs or other genome informatics resources, will require a separate infrastructure for access and dissemination.  In these cases, both the hardware and software components of this infrastructure must be described.  The utility of the dissemination activity must be described along with the process for improving the resource in response to community needs and input.  Any web-based dissemination activities must emphasize user-centric design. 

In all cases, the materials or data should be made available rapidly after verification of the data quality, as outlined in the NHGRI Data Release Policy http://www.genome.gov/10506376.

A robust web presence may be appropriate for informatics resources and some other types of resources.  If appropriate, the web site should provide information about:

(1) the project’s focus and capabilities, including research objectives if appropriate;

(2) how to interact with the resource and provide feedback;

(3) contact information;

(4) current newsworthy items;

(5) links to online tutorials, if appropriate;

(6) the availability of software, reagents, and other resources, as applicable; and

(7) links to related NIH-funded resources.

Training (optional)

Some projects will generate resources that require training to maximize their utility.  Where appropriate, the application must describe a plan and allocate sufficient resources for training both specialists and non-specialists to make the best use of the resource.  Examples include presentations, short courses, or symposia offered independently or in conjunction with society meetings attended by the user community; web-based tutorials; and user manuals and training guides to describe the features of the resource. 

Administration and management (required for complex projects)

The administrative structure of the project should be described.  This section should be broken down into organizational structure and staff responsibilities, progress reporting, and the Scientific Advisory Board.

Organizational structure and staff responsibilities

The organizational structure of the project should be described.  Issues that should be addressed include how the principal investigator and the project staff will be organized with respect to the project activities, the scientific and technical expertise of the staff who will develop and run the resource development activities, and their distribution of effort across their areas of responsibility. 

Scientific Advisory Board

A Scientific Advisory Board (SAB) should be appointed by the principal investigator (PI) to advise the PI on progress and priorities of the resource project.  In consultation with the SAB, the project must set priorities for the types and depth of information to be included.  The SAB should encourage continuous improvements as methods, data, and needs change with time.  A strong emphasis on operating in a cost-effective manner should be established.  Applicants should describe previous experiences with advisory panels, how advice was incorporated into a project, and how the advice contributed to a project’s outcome.  Applicants should describe how they plan to organize advisory board meetings and agendas.  The report from the last SAB meeting should be submitted as part of the annual progress report to NHGRI.  New applications should not name the proposed SAB members, but should describe the expertise to be included on the SAB.  Funds should be requested in the Consultant Costs category of the budget to support SAB travel expenses for an annual meeting.  

Special requirements for informatics community resource projects

This section is part of the 30 pages of the Research Strategy.

These projects include model organism databases and other informatics resources that involve curation of data from the literature and integration with other genomic or genetic data.  In these cases, the application should also address the following issues:

1.  The various data types to be included in the resource:  The application should present a rationale for including or excluding particular data types (incorporating community priorities), and should provide a plan for adding new data types as they arise.  In addition to the main data types that are the focus of the resource, the resource should also include types of evidence, measures of data quality, descriptions of curation methods and associated metadata, and attribution of data sources, for both experimental and computational data. 

2.  The curation processes to be used:  These should be fully described and justified.  Processes addressed should include high-quality manual and computational methods as well as extraction of information from the literature.  The application should describe the plans to present the curated data and descriptions of the curation process to users.  The application should outline the controlled vocabularies that will be used to describe the data.  The application should list the amounts of the various data types to be curated. 

3.  The quality control procedures to be used:  The development and use of various quality control methods are encouraged, but should be justified based on how they benefit the resource and avoid generating erroneous data and propagating errors to automatically annotated records.  The proposed metrics of data quality should be described, including discussion of how comprehensive the data will be.  The application should indicate the values of these quality metrics that the resource expects to reach.

4.  The plans for maintaining the stability of the resource:  Issues that should be addressed include, but are not limited to, the frequency of data versioning, API (application programming interfaces) and web services modifications, changes to data cross-referencing with other sources, and consistency of user interfaces.

5.  Any plans to leverage and integrate data from other genomics resources:  The application should explain which resources were chosen and why the data are appropriate for inclusion in the proposed resource.  If data from existing resources that provide similar or overlapping information are included, the application should justify their value and how unnecessary duplication will be avoided.  Applications should discuss how the resource will clearly attribute data to other resources.

6.  Any plans to coordinate with related resources:  This may include playing an active role in securing agreement on controlled vocabularies and common data exchange formats where necessary.  Applicants should discuss their track record in coordinating with other resources.

7.  Any plans to improve manual curation:  This includes ensuring that manual curation is efficient and that curators have the appropriate training and tools.  The application should describe the types of curation tools needed to generate the information for the resource.  The application may describe tools in use as well as propose the development of improved or new tools, which should be focused on the needs of the project.

8.  Any plans to scale up the curation process:  This includes the development of scalable methods to speed up both manual and computational curation processes and to incorporate large data sets.  The development of these methods should be focused on the resource rather than being open-ended research activities.  These methods should enable the resource to curate large data sets more effectively.

9.  The plans to provide data access:  The data should be easily accessible by the scientific community.  It would be appropriate to employ multiple methods of querying, including simple web interfaces for standard queries and tools such as APIs (application programming interfaces) or web services for more complex queries.  The application should provide information about the applicant’s experience with building interfaces, and statistics on their use.  Applications should describe the plans to make the data, data schema, and tools in the resource downloadable by users.

10.  If appropriate, how community annotation would be incorporated into the resource:  Providing such a mechanism is recognized as a challenge, but efforts should be made to engage the user community and benefit from its knowledge.  Applications should describe how this information would be solicited, vetted for quality, incorporated into the project, and attributed to authors.

11. The plans for a user support service:  The project may need to provide consultation and technical assistance to those using the resource.  Applicants should describe their experience in providing user support, evidence of the quality of that service, and the plans to implement or continue this service.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the PHS398 Application Guide.  Note that applications from foreign organizations or with components from foreign organizations must provide detailed justification for the value of the proposed work and resources and the unavailability of these resources in the U.S.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

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.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications for the March 15, 2011, receipt date must be received by March 15, 2011.  If an application is received after that date, it will not be reviewed.  Applications for subsequent standard receipt dates must be postmarked on or before the due dates in Part I. Overview Information. If an application is postmarked after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the PHS398 Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115..

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact


Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  Is the proposed resource valuable for the broad genomics research community?  

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  Have the investigators demonstrated that they have shared resources previously? 

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?  Is the amount of novelty proposed appropriate for the resource proposed?

For informatics community resource projects:  Will the proposed resource continually be able to incorporate new data types or data produced by new technologies?  Will the resource develop new scalable methods to speed up manual and computational annotation?  Will the resource develop new ways to meet the needs of its user communities?  Will the resource develop appropriate methods for soliciting, collecting, vetting, and incorporating community annotation?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Needs assessment:  The applicant is responsible for identifying the research communities that will use the resource.  How is the balance of the component activities proposed consistent with the needs and opportunities presented by the potential user communities? 

Community outreach:  How adequate are the plans to inform the scientific community about the resource?

Resource maintenance:  How adequate are the plans to collect and maintain data?  How adequate are the plans to ensure that curation is accurate and that error propagation is minimized?

Resource access:  How adequate are the plans for researchers to be able to access the resource data, including plans to make available the entire resource and data schema?

Service:  How adequate are the plans to provide consultation and technical assistance in the use of the resource?

Training:  How adequate are the plans for providing educational programs to explain to members of the research community how to use the resource?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, 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 for recommended 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.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NHGRI (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Human Genome Research . The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. . More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) 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, 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.

The PD(s)/PI(s) will have the primary responsibility for:

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

Areas of Joint Responsibility include:

Dispute Resolution:

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 Dispute Resolution. A Dispute Resolution 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 dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Dr. Vivien Bonazzi
Program Director, Genome Informatics
Division of Extramural Research
National Human Genome Research Institute (NHGRI)
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

Dr. Lisa Brooks
Program Director, Genetic Variation
Division of Extramural Research
National Human Genome Research Institute (NHGRI)
5635 Fishers Lane, Ste. 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: brooksL@mail.nih.gov

Dr.  Peter Good
Program Director, Genome Informatics and ENCODE
Division of Extramural Research
National Human Genome Research Institute (NHGRI)
5635 Fishers Lane, Ste. 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: goodp@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Ms. Cheryl Chick
Grants Administration Branch
National Human Genome Research Institute (NHGRI)
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892-9306 (U.S Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-402-0733
Email: chickc@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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 Part 52 and 45 CFR Parts 74 and 92.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH . . . Turning Discovery Into Health

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.