Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS)

Funding Opportunity Title

Technology Development for Protein Modeling (R01)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of PAR-10-076

Related Notices

  • March 14, 2014 - See Notice NOT-GM-14-108. Notice of Early Termination.
  • March 12, 2014 - See Notice NOT-GM-14-110. Notice of Termination of NOT-GM-08-123
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

PAR-13-033

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.859

Funding Opportunity Purpose

This FOA issued by the National Institute of General Medical Sciences (NIGMS), National Institutes of Health, encourages grant applications from institutions/organizations that propose to develop novel technologies that will significantly improve the accuracy of comparative modeling methods for protein structure prediction.

Key Dates
Posted Date

November 30, 2012

Open Date (Earliest Submission Date)

January 5, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates apply

Expiration Date

(Now Expired March 15, 2014 per NOT-GM-14-108), Originally January 8, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (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

The purpose of this FOA is to encourage grant applications that propose to develop novel technologies that will significantly improve the accuracy of comparative modeling methods for protein structure prediction. The two main goals of this FOA are to increase the quality of protein structure models to a level comparable to high-resolution X-ray crystal structures when known structures are available with 30% sequence identity to the modeling targets, and to increase model quality to 2 Angstroms RMSD (Root Mean Squared Deviation) or better when known structures are available with as low as 10% identity to the targets.

Background

This FOA is part of the NIGMS initiative, PSI:Biology.  [http://www.nigms.nih.gov/Initiatives/PSI/Biology/] PSI:Biology represents a significant shift in focus for the Protein Structure Initiative (PSI).  The PSI was initiated in FY2000, after extensive dialog with the scientific community, with the ultimate goal of significantly advancing the understanding of the relationship between the sequence of a protein and its three-dimensional structure.  See: http://www.nigms.nih.gov/Initiatives/PSI/ and http://grants.nih.gov/grants/guide/rfa-files/RFA-GM-05-001.html for extensive discussion of the initial goals of the PSI and of structural genomics in general.

In 2008, the PSI Advisory Committee made a number of recommendations about how the PSI might be restructured and refocused, including realigning the mission of any large-scale centers to focus on biologically important questions that would be pursued in partnership with the broader community of scientists.  The committee concluded that a number of components of the PSI could be satisfactorily competed and supported through program announcements (PAs); specifically, technology developments for specific stages in the determination of protein structures and methods for improving homology modeling. Based on these recommendations, NIGMS staff presented a Concept Clearance document to the Council at its January 2009 meeting, and the Council approved the plans which resulted in the establishment of PSI:Biology.

Objectives

Applicants of this FOA should be focusing on one or both of the following two main goals:

1) Near-Crystal-Structure Quality for Close Homologs of Known Structures

The first scientific goal of this FOA is to approach the standard of high-resolution X-ray crystal structure quality for comparative models that are based on known structures with 30% or higher sequence identity to the modeling targets. This is predominantly a high-accuracy refinement problem, although substantial improvement of alignment methods is also required. The aim is to acquire the ability to reliably produce computational models with highly accurate placement of both backbone and side chain atoms, and to significantly reduce the need for experimental structure determinations for close homologs of known structures.

2) High-Accuracy Models for Remote Homologs of Known Structures

The second scientific goal is to expand the modeling coverage to more distantly related proteins that exhibit as low as 10% identity to any known structures. The quality of these models should be close to X-ray structures or high-resolution NMR structures with less than 2 Angstrom RMSD for backbone and side-chain atoms. This is both an alignment problem and a refinement problem. Significant improvement of modeling methods is needed to push the modeling coverage to remote homologs of existing structures without much compromise on quality.

Through this FOA, the NIGMS is committed to achieving these two goals. Applicants must identify which of the modeling goals (or both) the application addresses. Applicants should propose intermediate goals and deliverable milestones within the funding period. Although not the main goal, some practical applications of structure modeling may be incorporated as components of the research. These may include: establishing benchmarks and standards for model quality assessment and uncertainty estimation; developing methods that will accurately predict structural changes caused by small mutations; combining computational approaches and high-throughput experimental approaches to develop novel hybrid methods; improving ab initio methods for loop modeling; improving server and meta-server methods; collaborating with other scientists to promote utilization of models in functional studies. Applicants may also propose other research, but all activities should be in support of targeting the main goals above. The technologies developed under this program should be generally applicable and scalable for application to a broad range of proteins, rather than to a limited number of special groups of proteins.

This FOA aims to promote collaborative research and exploratory approaches in developing novel comparative modeling technology.  Applications from new investigators and established investigators in mathematics, physics, computer science, statistics, or other quantitative disciplines who are new to protein structure modeling are encouraged.  Investigators currently supported to work on protein homology modeling are eligible to apply.  However, their contributions to this program must not overlap with or be simple extensions of their supported studies.

This program is a component of NIGMS PSI:Biology. The goal of the PSI:Biology is to test whether the new paradigm of high-throughput structure determination via highly organized networks of investigators can be applied to a broad range of biological problems.  It consists of five main components:  1) Centers for High-Throughput Structure Determination; 2) Centers for Membrane Protein Structure Determination; 3)  Consortia for High-Throughput-Enabled Structural Biology Partnerships; 4) the PSI-Structural Genomics Knowledgebase; and 5) the PSI-Materials Repository; plus three additional components supported through on-going FOAs: a)  Technology Development for High-Throughput Structural Biology Research; b) Technology Development for Protein Modeling; and c) High-Throughput-Enabled Structural Biology Research. The core of the PSI:Biology network consists of investigators from these components who will be expected to establish meaningful collaborative interactions with  PSI:Biology researchers. The network will be managed collectively through the PSI:Biology Network Steering Committee which will include representatives of the PSI:Biology components and NIH staff.

Participation in the PSI:Biology network is required, including collaboration with other investigators of PSI:Biology. Applicants will be required to make their homology models available for deposit in the PSI:Knowledgebase. Applicants must describe in the Research Strategy portion of the application how they intend to participate in the network of interactions among members of PSI:Biology. Examples of collaboration may include modeling proteins that are homologs of the structures determined by the PSI:Biology centers, modeling structural genomics targets prior to release of their experimental structures by the PSI:Biology centers for quality assessment of the modeling algorithms, providing feedback to PSI:Biology centers for refinement of target selection strategies, or development of hybrid approaches by combining computational methods with high-throughput experimental data to increase model quality. Participation in PSI:Biology activities, such as meetings held jointly with other PSI:Biology participants is expected. Other forms of collaboration with the PSI:Biology centers [http://www.nigms.nih.gov/Initiatives/PSI/Biology/] or other large-scale experimental structure determination projects are also encouraged. Additional plans to engage the user community and to encourage feedback to improve quality and utilization of models should also be included. The PSI Knowledgebase hosts a portal for homology models generated by the PSI:Biology centers and other sources and is active in development of metrics for model quality. Collaboration with the PSI Structural Biology Knowledgebase in modeling-related activities is required. The plans for interactions with PSI:Biology will be evaluated during peer review and must be approved by NIGMS staff prior to award.

Software Sharing

Software developed under this program is expected to be freely available to all biomedical researchers and educators.  There is no prescribed single license for software produced under this program.  The terms of the software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.  The terms of software availability should also include the ability of researchers outside the project to modify the source code and to share modifications with other colleagues as well as with the original developer.  The application should include a written statement from the officials of the institution responsible for intellectual property issues, to the effect that the institution supports and agrees to abide by the software dissemination plans put forth in the application.  The plan for software sharing will be evaluated during peer review, and the final version of any accepted software sharing plans will become a condition of the award of the grant. The software sharing plan should be included as part of the Resource Sharing Plan.

Commitment to Diversity

The NIGMS is committed to promoting and advancing the diversity of the scientific workforce (see  http://www.nigms.nih.gov/News/Reports/workforcediversity_100307.htm). Applicants responding to this FOA must propose creative ways to enhance and/or successful ways to ensure continued diversity on their research teams.  Reports from the National Science Foundation (see http://www.nsf.gov/statistics/wmpd) and the National Academy of Sciences emphasize the need for a well-trained diverse scientific workforce (http://www.nap.edu/catalog.php?record_id=12984). 

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

A.  Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the report Women, Minorities, and Persons with Disabilities in Science and Engineering, 2007, p. 262).   The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans or Blacks, Hispanic Americans or Latinos, American Indians or Alaska Natives, Native Hawaiians or other Pacific Islanders.  In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be included in the recruitment and retention plan.

B.  Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds.  These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs.   The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml.   For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates (a) have qualified for Federal disadvantaged assistance; or (b) have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program; or have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.

The PSI:Biology research groups should reflect the resolve of the NIH and NIGMS to enhance the diversity of the scientific workforce and should include a recruitment and retention plan for increasing workforce diversity.  The plan should be included under a separate heading in the Research Strategy section.  FAQs on Recruitment and Retention Plans may be found at http://grants.nih.gov/training/faq_diversity.htm.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission

The OER Glossary and the SF424 (R&R) 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 need to reflect actual needs of the proposed project.

Award Project Period

The maximum period is 5 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 Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as  NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF424 (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(s)/PI(s)) 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 6 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(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 SF424 (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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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 submission of applications for this FOA. 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:

Research Strategy

Scientific Goals

As discussed in Section I (Objectives), applicants of this FOA may focus on modeling goals appropriate to either close or remote homologs of know structures.  Applicants must identify which of the modeling goals (or both) the application addresses. Applicants should propose intermediate goals and deliverable milestones within the funding period.

Network Participation

As discussed in Section I (Objectives), participation in the PSI:Biology network is required, including collaboration with other investigators of PSI:Biology. Applicants must describe in the Research Strategy portion of the application how they intend to participate in the network of interactions among members of PSI:Biology.

Diversity

Applicants should present their proposed Recruitment and Retention Plan under a explicit heading.

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 modification:

Software Sharing Plan

A software dissemination plan, with appropriate timelines, is expected to be included in the application.  There is no prescribed single license for software produced through grants responding to this announcement.  However, NIH does have goals for software dissemination, and reviewers will be instructed to evaluate the dissemination plan relative to these goals:

1.  The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. 

2. The terms of software availability should permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.

3. To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

4.  The terms of software availability should include the ability of researchers to modify the source code and to share modifications with other colleagues.  An applicant should take responsibility for creating the original and subsequent “official” versions of a piece of software.

5.  To further enhance the potential impact of their software, applicants are expected to propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others.  This proposal may include a plan to incorporate the enhancements into the “official” core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.

The adequacy of the software sharing plans will be considered by program staff when making recommendations about funding applications. In making such considerations, prior to funding, program staff may negotiate modifications of software sharing plans with the Principal Investigator(s) before recommending funding of an application. Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plan.

The final version of any accepted software sharing plans will be referenced as a condition of the award of the grant. The effectiveness of software sharing may be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590).  See Section VI.3., “Reporting.”

Intellectual Property

An institution's stance must be consistent with the goals of advancing and not hindering future research. Refer to the NIH Intellectual Property Policy for more details. The application should include a written statement from the officials of the institution(s) responsible for intellectual property issues, to the effect that the institution supports and agrees to abide by the NIH Intellectual Property Policy. This letter should be included as an attachment to the Letters of Support section.

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 Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions 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 applications before 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 before the deadline 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 SF424 (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(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(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 System for Award Management (SAM). 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, 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 SF424 (R&R) 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 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?  

Investigator(s)    

Are the PD(s)/PI(s), 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? If there is an investigator on the research team from a discipline such as mathematics, physics, computer science, statistics, or other quantitative discipline and who is new to protein structure modeling, is that investigator contributing in a significant way to the studies proposed?  

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 application develop new methodologies or technologies that substantially improve the quality of protein structural modeling?   

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?

Will the plan for collaboration with other members of the PSI:Biology network enhance the ability to obtain near-crystal-structure quality for close homologs of known structures and/or high-accuracy models for remote homologs of known structures)?

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 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

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

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 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; 3) Genome Wide Association Studies (GWAS); and 4) Software Sharing.

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 Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications 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 appropriate national Advisory Council or Board. 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’s 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, SAM 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 annual Non-Competing Progress Report (PHS 2590 or RPPR) 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)

Ward Smith, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-443-9375
Email: Ward.Smith@nih.gov

Peer Review Contact(s)

Noni Byrnes, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1023
Email: byrnesn@csr.nih.gov

Financial/Grants Management Contact(s)

Earl C. Melvin
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3912
Email: melvine@nigms.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.


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