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

Technology Development for High-Throughput Functional Genomics (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HG-11-013

Companion FOA

RFA-HG-11-014, R21 Exploratory/Developmental Grant, and RFA-HG-11-015, R43/R44, Small Business Innovation Research Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.172

FOA Purpose

NHGRI is soliciting grant applications to develop new and improved technologies for the efficient, comprehensive and high-throughput identification, validation and characterization of all types of sequence-based functional elements in eukaryotic genomes. This FOA will use the R01 (Research Project) grant mechanism and is being used in conjunction with FOAs with identical scientific scopes, RFA-HG-11-014, that solicits applications under the R21 Exploratory/Developmental grant mechanism, and RFA-HG-11-015, that solicits applications under the R43/R44 Small Business Innovation Research grant mechanism. This solicitation continues a technology development effort initiated in 2003 as part of the ENCODE project.

Key Dates
Posted Date

May 23, 2011

Open Date (Earliest Submission Date)

July 2, 2011

Letter of Intent Due Date

July 2, 2011

Application Due Date(s)

August 2, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November, 2011

Advisory Council Review

February, 2012

Earliest Start Date(s)

April, 2012

Expiration Date

August 3, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) 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. 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 the 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

Purpose:

NHGRI is soliciting grant applications to develop new and improved technologies for the efficient, comprehensive and high-throughput identification, validation and characterization of all types of sequence-based functional elements in eukaryotic genomes. This FOA will use the R01 (Research Project) grant mechanism and is being used in conjunction with the following FOAs that have the identical scientific scope: RFA-HG-11-014, which solicits applications under the R21 Exploratory/Developmental grant mechanism and RFA-HG-11-015, which solicits applications under the R43/R44 Small Business Innovation Research grant mechanism. This solicitation continues a technology development effort initiated in 2003 as part of the ENCODE project.

Background:

The long-term goal of the Encyclopedia of DNA Elements (ENCODE) Project is to identify comprehensively all of the sequence-based functional elements in the human genome. modENCODE is a parallel effort to annotate comprehensively the genomes of C. elegans and D. melanogaster. In addition, with funds from the American Recovery and Reinvestment Act (ARRA) of 2009, a small, two-year effort was supported to generate related data from the mouse that could facilitate the annotation of the human genome. For the purpose of this solicitation, these efforts will collectively be referred to as the “ENCODE projects.” For more information about the ENCODE projects, see: www.genome.gov/ENCODE.

Functional elements that have been studied in ENCODE include transcribed sequences, regulators of transcription (including enhancers, promoters, and insulators), and regulators of RNA transcripts themselves (at the levels of splicing, translation, and stability). Using a variety of high-throughput methods, such as RNA-seq, ChIP-seq and DNase-seq, these functional elements have been identified by mapping different types of “marks,” including transcription factor binding sites, histone modifications, various measures of chromatin structure, sites where RNA-binding proteins bind, and different classes of transcribed sequences. These growing catalogs of functional elements are directly adding to our general understanding of genome structure and function, and enable targeted research projects examining the role of these elements in the regulation of genes of interest. Furthermore, as genetic and epigenetic variation at these elements may be responsible for some observed phenotypes, comprehensive identification of functional elements is also expected to enhance our understanding of human health and disease.

The ENCODE projects have been very successful to date in generating large amounts of high-quality data that are being used by the research community and have led to the understanding of a great deal of functional genomic information. Importantly, analyses that have integrated the datasets within and across a variety of cell types for a given organism have amplified the amount of useful information that has been derived from the data (See: Nature 447:799-816, 2007; Science 330:1775-1787, 2010; Science 330:1787-1797, 2010; PLoS Biol 9:e1001046, 2011). The use of multiple cell types and multiple assays is, in fact, key to obtaining a comprehensive description of the functional elements in these genomes, as there is no one cell type or type of assay that can be used to identify all functional elements. But limitations in technology and available resources currently limit the application of all assays to all cell types of interest. It is for this reason that, while the ENCODE projects are on track to meet their current goals, achievement of those goals will still fall short of achieving a truly comprehensive view of the structure of the functional elements in these important genomes.

The development and use of new technologies have been important in bringing the ENCODE projects to their present state. However, it is likely that continued incremental improvements in current technologies will not be sufficient to create high-quality and truly “complete” catalogs within a reasonable timeframe and cost; rather, revolutionary improvements in analytical capability will be needed to achieve comprehensiveness. This is particularly the case for human and mouse, due to the challenges posed by the much more complex genome sequences, the large number of cell types and the limited availability of tissues for study (particularly for human). Assays with significantly greater throughput and sensitivity, as well as significantly reduced cost, will be required for identifying, validating and characterizing functional elements in eukaryotic genomes in a comprehensive manner. For example, the number of cells currently required for most assays is typically in the millions, so most of the results to date have come from cell lines, which may or may not adequately represent in vivo conditions. Similarly, while some work has also been done using tissue samples, the mixed cellular nature of most tissues precludes analysis of relatively rare cells in mixed populations or in cases in which the quantity of tissue available is very small. For these reasons, it will be critically important to have technologies that will allow single cell analysis. The relatively high cost of using the technologies now available (e.g., ~$5,000 per replicated and analyzed ChIP-seq experiment) limits the number of cell types that can be assayed for functional elements, and limits the use of these assays by the broader biomedical community. Finally, the lack of effective, practical high-throughput methods prevents the study of some types of functional elements at a genome-wide scale. For these reasons, revolutionary improvements in methods to study functional elements are needed.

The data produced by the ENCODE projects are critical to advancing further research in understanding the rules by which genome sequences are read and genetic information is expressed, as well as for understanding how genetic variation gives rise to different phenotypes. Development of better experimental approaches to model gene regulation at a genomic scale is needed to address these important fundamental questions and to allow us to begin to understand the role of variation within functional elements in human health and disease.

Beyond the need for new technology to identify functional elements and to study variation in them, significant methodological improvements are also needed to address the validity of the identification methods in terms of our understanding of the biological role that these elements play. For example, many of the current methods used in the ENCODE projects identify putative functional elements through the use of surrogate marks, such as histone modifications, which appear to be associated with particular specific biological functions. High-throughput methods are needed to validate these inferred biological roles (e.g., enhancers, insulators, regulators of splicing) to enhance the value of the ENCODE datasets. Current assays, often using plasmid-based reporter assays, cannot readily be scaled to meet the challenge of testing the tens of thousands of functional elements identified by the ENCODE projects. Furthermore, such assays frequently use techniques such as transient transfection that may result in non-physiological conditions (such as partially assembled chromatin) which may lead to non-relevant results. Finally, as it is clear that, almost always, these elements do not function in isolation, high-throughput methods are also required to determine which functional elements work together to regulate gene expression and to identify which elements regulate which genes. Ultimately, this work must enable tests of predictive models that describe how functional elements interact to drive gene expression.

In addition to experimental methods for biological validation of functional elements, computational methods that integrate functional genomics data can be used to make predictions of the biological roles of functional elements identified by high-throughput methods. At present, while these computational methods can provide possible clues to biological function, they lack sufficient sensitivity or specificity to provide a true gold standard reference for the larger community. Having improved computational methods to identify and characterize the biological roles of function elements will greatly enhance the utility of the ENCODE Project data.

Research scope:

The NHGRI wishes to continue its efforts to stimulate the development of novel technologies and to expand the available “tool box” of methods that can be used for the comprehensive identification and functional testing of sequence-encoded elements in a high-throughput manner. This FOA seeks applications for research projects to develop efficient technologies (both experimental and computational) that have the promise to result in revolutionary advances in the state-of-the-art for, but not limited to, the following areas:

A: High-throughput, genome-wide experimental methods for finding functional elements that:

B: High-throughput experimental methods for biological validation and characterization, for example:

C: Computational methods to characterize functional elements, for example:

These few examples are illustrative and should not be considered to be limiting in any way. Novel and innovative technologies to achieve high-throughput, genome-wide identification of any type of sequence-encoded functional elements or to increase throughput of biological validation assays are sought.

The "process" of technology development can be considered to span a spectrum of stages. Initially, it involves the development of an entirely new methodology (or the significant improvement of an existing methodology) to the point of proof of principle. The method must then be reduced to practice. For such a new method to have a significant impact for genomic studies, it also must be developed to the point at which it can be used efficiently on a large-scale, or genomic, basis. This FOA is intended to solicit applications that address any of these phases of technology development, with an emphasis on the development of completely novel techniques or revolutionary advances, although orders-of-magnitude improvement of existing methods are also encouraged.

Although the ENCODE projects are currently focused on establishing a comprehensive understanding of the human, C. elegans and D. melanogaster genomes, this FOA is open to projects that employ any eukaryotic organism. If such another system is proposed, the applicant must address the issue of the generality of application of the technology to other eukaryotic genomes, especially the human genome.

Applicants should describe their plan for determining the capability of their technology to be used in a high-throughput, production setting to generate high-quality data.

The scientific and technical challenges inherent in achieving these revolutionary technology improvements are significant. A detailed research plan must be presented. The application should include a description of the level of risk of key technical challenges, alternative approaches, go/no-go decision points, etc. It should also include a detailed timeline accompanied by quantitative milestones that address the key scientific and technical challenges central to the approach. The timeline and milestones are essential for planning the research project, evaluating the proposal, and assessing progress toward goals. It will be particularly important to establish quantitative milestones in cases where subsequent steps in technology development depend upon threshold performance characteristics of earlier developments. Achieving these goals may require research projects that entail substantial risk. That risk should be balanced by an outstanding scientific and management plan designed to achieve the very high payoff goals of this solicitation. High-risk/high-payoff projects may fail for legitimate reasons, so applicants proposing such projects should identify them as such, elaborate key quantitative milestones to be achieved, and describe the consequences of not achieving those milestones in a reasonable period of time.

The development of computational methods for the study of genomic function is encouraged under this solicitation. However, computational methods that are incremental improvements on existing methods and that don’t lead to significant advancements in computational methods to find and characterize functional elements will not be considered to be responsive. Applications that propose computational methods should have a component for experimental work to validate the specificity and sensitivity of any computational predictions.  Any software developed under this FOA should be freely available to other biomedical researchers in the non-profit sector.

An important feature of any newly-developed technology will be the ease with which it can be adopted by other laboratories, or in other ways made readily accessible to other investigators. The issues of access and technology transfer should be specifically discussed in the grant application.

Since the technologies to be developed under this FOA are specifically intended for whole genome analysis, applications proposing methods that will be limited to the analysis of a particular gene, gene family or non-coding functional element will not be considered to be responsive. The development of new sequencing platforms is not a primary goal of this FOA, nor is simply substituting the latest, commercially available sequencing platform for the current generation; such applications will also be considered to be non-responsive. Projects to apply current technologies to identify functional elements are also not responsive to this FOA. However, during the course of development, it is expected that a limited number of assays will need to be performed to demonstrate the accuracy and reproducibility of a newly developed technology.

As the work funded under this FOA progresses, the principal investigators will be encouraged to interact with participants in other components of the ENCODE projects. If work supported under this FOA results in the generation of genome-wide data of the organisms studied in ENCODE, the principal investigators may be invited to join the Consortium (see: http://www.genome.gov/12513439 for a description of the Criteria for participation in the ENCODE Consortium). Among other requirements, this would involve sharing of the data with the members of the Consortium, as participation involves concurrence with a specific data release policy (see: http://www.genome.gov/27528022 for a detailed description of that policy). Applicants to RFA-HG-11-013 may wish to address their approach to data release in their application.

Development of this FOA was informed by discussions raised at an Institute-sponsored workshop on the “Genomics of Gene Regulation” (See: http://www.genome.gov/Pages/About/Planning/October2009_GenomicsGeneRegulation.pdf), and by discussions with the National Advisory Council for Human Genome Research. 

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NHGRI intends to commit a total of $5 million dollars in FY 2012 to fund applications submitted in response to this FOA and its companion RFA-HG-11-014. Between 10 and 14 awards will be made. Awards issued under this FOA are contingent on the availability of funds and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets need to reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 3 years.

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 SF 424 (R&R) 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 (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program 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 SF 424 (R&R) 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.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) 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, e-mail 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 should be sent to:

Michael J. Pazin, Ph.D.
Program Director
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
FAX: 301-480-2770
E-mail: pazinm@mail.nih.gov

Please transmit Letter of Intent by email to: pazinm@mail.nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

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 SF424 (R&R) Application Guide, with the following modifications:

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) 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 SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

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 must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NHGRI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Applicants may include funds for an advisory board.  The role of the advisory board should be described, including how often it will meet, what types of scientific expertise will be needed on the board, and what specific activities will be performed by the board members.  However, applicants should not contact potential advisors prior to the review of the application, nor should potential advisors be named in the application to avoid conflict of interest in the review process.

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? Are the plans sufficiently bold to constitute a substantial advance, if they can be achieved, toward revolutionary improvements in these technologies? Do the computational methods propose new approaches that will significantly improve on characterizing functional elements or does the computation work represent incremental improvements on existing methods? 

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?   

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? Does the project propose to develop new methods or technologies that will reduce costs, increase sensitivity, increase throughput and/or increase quality by orders of magnitude?  

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.

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

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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 the NHGRI, in accordance with NIH peer review policy and procedures, using the stated review criteria.  Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned  to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. 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

Not Applicable.

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 the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

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)

Michael J. Pazin, Ph.D.
Program Director
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
FAX: 301-480-2770
E-mail: pazinm@mail.nih.gov

Peer Review Contact(s)

Rudy Pozzatti, Ph.D.
Scientific Review Officer
Scientific Review Branch
National Human Genome Research Institute (NHGRI)
5635 Fishers Lane, Ste. 4076, MSC 9306
Bethesda, MD 20892-9305 (U.S Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-402-8739
FAX: 301-435-1580
E-mail: pozzattr@mail.nih.gov.

Financial/Grants Management Contact(s)

Cheryl Chick
Grants Administration Branch
National Human Genome Research Institute (NHGRI)
5635 Fishers Lane, Suite 3058
Bethesda, MD 20892-9307
Phone: 301-435-7858
Fax: 301-451-5434
E-mail: 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


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