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)
National Center for Complementary and Alternative Medicine (NCCAM)

Funding Opportunity Title

Genomes to Natural Products (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

  • March 5, 2014 - This RFA has been reissued as RFA-GM-15-001.
  • March 12, 2013 - See Notice NOT-GM-14-106. Notice of Pre-Application Meeting.
  • March 12, 2013 - See Notice NOT-AT-13-005. Notice of NCCAM's Participation.

Funding Opportunity Announcement (FOA) Number

RFA-GM-14-002

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, 93.213

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) solicits applications that utilize the wealth of genomic and metagenomic sequencing data available, and recent advances in synthetic biology for the purpose of developing new high-throughput and broadly applicable approaches to natural products discovery. Well-integrated, collaborative research teams possessing synthetic biology, bioinformatics, and natural products expertise are encouraged to apply. Applicants responding to this FOA must also plan for participation in trans-network activities, including collaborative projects with other network participants.

Key Dates
Posted Date

March 1, 2013

Open Date (Earliest Submission Date)

June 17, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

July 17, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October/November 2013

Advisory Council Review

January 2014

Earliest Start Date

May 2014

Expiration Date

July 18, 2013

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

This Funding Opportunity Announcement (FOA) seeks to speed the rate of discovery of natural products through development of genome and synthetic biology based platforms thus overcoming present technical and knowledge barriers in natural products discovery and in the ability to translate the genetic code (biosynthetic genes) into a chemical read-out (natural products).

Research Objectives

This FOA solicits applications from multidisciplinary research teams with well-integrated genomics, synthetic biology, and bioinformatics expertise, to develop innovative, high-throughput, and broadly applicable genome-based methods for natural products discovery that overcome technical barriers and fill knowledge gaps for translation of genetic information into chemical information.

The research proposed should:

Studies conducted under this FOA will advance our current understanding of biosynthetic pathways, regulatory networks, and chemical scaffolds encoded in natural product producers' genomes. It is also anticipated that new tools, model production organisms and chemical methods for high-throughput and broadly applicable natural products production and characterization will be developed. Tools and technologies developed under this FOA should be an integral part of a novel approach that allows for the rapid determination of the potential of an organism as a natural products producer.

Background

Optimized through evolutionary genetic processes for their biological activity, natural products serve as defensive and signaling molecules, and impart defining chemical features that help make organisms biologically distinct. Approximately 75% of antibacterial and anticancer drugs are natural products or inspired by natural products. Despite their impact, the discovery process for natural products has conceptually and technically not changed over the past three decades. This “grind and find” method entails identification of natural products through biological or phenotypic screening of partially purified mixtures of compounds obtained from cultivable organisms. Thus, this method is limited to organisms that can be cultured and whose biosynthetic operons are sufficiently expressed under culture conditions to provide assayable amounts of active material. These intrinsic limitations have led to a significant reduction in the rate of new discoveries. Recent studies of known natural products' producers suggest that less than 1% of bacteria and fungi can be cultivated and of these, only a small fraction of their natural product operons are active under culture conditions. This suggests that the current approach to discovery of natural products has barely tapped into the potential pool of encoded products.

The last decade has witnessed rapid technical advances and cost-reduction in DNA sequencing, DNA synthesis, and DNA cloning, enabling the sequencing of a wealth of genomes and metagenomic DNA. These technical advances and abundance of sequencing data have opened opportunities for an entirely new approach to natural products discovery that overcomes current limitations. Now it is realistic to use the genomic information to infer the structure of natural products and to leverage advances in synthetic biology to engineer model microorganisms for the production of natural products. This initiative seeks to rapidly expand the pool of natural products by addressing technical and knowledge barriers to the development of genome-based natural products discovery approaches that can take advantage of advances in synthetic biology and the wealth of genomic and metagenomic data being generated across the world.

Specific Areas of Research Interest

For this FOA, specific topics of interest include, but are not limited to, those listed below:

Topics excluded under this FOA are:

This FOA seeks to achieve its scientific goals by promoting highly interactive partnerships that strongly integrate synthetic biology and the natural products expertise necessary to overcome challenges in natural products discovery. Research teams should include specific expertise to reach their goals including but not limited to:

Special Requirements

The Genomes to Natural Products Network and Governance

The cross-disciplinary research teams funded through this FOA in collaboration with interested and leading experts from academic, government, and industry will form the "Genome to Natural Products" Network (GNPN). The Network will be governed by a Steering Committee, which will provide overall leadership for the Network. Specifically, the GNPN will:

In out years, this FOA will support collaborative research projects and other joint GNPN activities among members of the GNPN with funds to be included in all budget requests. No description or plans for these projects are to be included in the Research Strategy Section (see Section IV.2.).

Membership of the GNPN

The GNPN will be composed of full members from the multidisciplinary project teams funded through this FOA and by affiliate members accepted for membership by the Steering Committee and approved by NIGMS.

Affiliate members

Affiliate members may be self-nominated or nominated by full members or by the NIH Project Coordinator. Their request for membership will be reviewed by the Steering Committee for benefit to the GNPN, and recommended to the NIH Program Official for approval. Affiliate members may be researchers from the non-profit and profit sectors. The GNPN Steering Committee may set a cap on the number of profit affiliate members. Affiliate membership of early career investigators is highly encouraged but should not constitute the majority of the non-profit affiliates.

Scientists selected as an affiliate members are expected to:

The GNPN Steering Committee will be the main governing body of the GNPN and will participate in setting directions, policies, and operating procedures. GNPN Steering Committee membership will include one voting member representing and appointed by each project awarded through this FOA, the NIGMS Project Coordinator who will serve as a voting member, and one non-voting member representing the affiliate members from the non-profit and profit sectors. The non-voting member will be nominated by the steering committee and must be approved by NIGMS. 

The Steering Committee Chair will be one of the voting members funded through this FOA, and nominated by the voting members of the committee. The chair must be approved by NIGMS. The chair may serve a renewable term of 2 1/2 years.

The GNPN Steering Committee will:

The GNPN External Scientific Advisory Committee (ESAC) will consist of three senior scientists appointed by the GNPN Steering Committee and approved by NIGMS, who will meet at the annual GNPN Scientific Meeting, and assess the progress of the GNPN in meeting its goals and milestones. They will advise the GNPN on proposed goals, milestones, and distribution of resources for the next year. The ESAC will provide its findings as a report to the GNPN Steering Committee, and to NIGMS. The ESAC's findings will advise the GNPN on how best to leverage resources and knowledge as a group, to achieve the greatest impact on and accelerate contributions to the field of natural products discovery. The NIGMS Project Coordinator will attend the meeting of the ESAC but s/he will not be a member of the ESAC.

Members of the ESAC should not be named in the application or contacted prior to the award.

Evaluations and Milestones

The NIGMS Director retains the right to call a meeting of scientific advisors at any time to provide advice on the scientific progress of the projects funded through this FOA and of the GNPN. The group of advisors may opt to attend a GNPN Steering Committee meeting.

It is expected that milestones will be adjusted and reported annually at the time of the non-competing continuation, both to incorporate the project's scientific accomplishments and progress in the field in general, as well as to reflect the recommendations of the ESAC and of any NIGMS advisor groups. Progress against milestones needs to be specifically addressed in the non-competing continuation.

Renewal

Only one renewal will be allowed for each award, limiting the total length of support under this program to a maximum of ten years.

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, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIGMS intends to commit $6,750,000 Total Costs in FY2014. The number of awards is anticipated to be 3.

Award Budget

Projects are limited to Total Direct Costs of $1,500,000 per year but total cost cannot exceed $2,250,000 per year.

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 not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the 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 must be followed, with the following exceptions or additional requirements:

The Research Strategy section is limited to 30 pages and it should be divided as follows:

Senior/Key Person Profile Expanded

This "Genomes to Natural Products" FOA is intended to support cross-disciplinary and collaborative research teams. Cross-disciplinary teams must include investigators with expertise in synthetic biology, bioinformatics, and natural products. Participation of early-stage and new investigators as part of the submitting cross-disciplinary research team is encouraged.

A substantial commitment (of at least 1.8 person months) is expected for any individual designated as PD/PI on the application. PDs/PIs of the GNPN and funded through this FOA will be required to maintain commitment at least at this minimal level of 1.8 person-month throughout the entire project period.

Each member/affiliate member of the GNPN should be performing state-of the art-science in research fields pertinent to this FOA and must agree to:

R&R Budget Component

The proposed research is intended to be managed as an overall unified program. Subprojects should not be designated. Awards will not be allocated to all individual PD(s)/PI(s) by the NIH and the Notice of Award will include only a single overall budget. Out year budgets should retain flexibility to accommodate emerging opportunities and meet workload needs as the research progresses. Consortium budgets should be included as necessary. Consortium subcontract indirect costs (Facilities and Administration, including F&A costs required to set up and maintain subcontracts) do not count against the upper direct cost budgetary limits for this announcement; however, they will count against the overall Total Cost limit.

The budget should include personnel, consultant costs, equipment, supplies and other expenses in support of work to be performed in the applicants' laboratories. Applicants should request funds to support travel to attend an annual meeting of all participating investigators. Compensation may be requested for members of the GNPN Steering Committee and of the GNPN ESAC for travel and effort to attend meetings of the GNPN as allowed by institutional policies. Applicants may request funds to support travel to one meeting with a symposium or session organized by and featuring the activities of the GNPN. Applicants must include in the budgets for the second and subsequent years $60,000 as a set-aside for GNPN collaborative projects. This budget item should be indicated in Section F of R&R Budget Component: Other Direct costs under item 8 as "Funds for GNPN Collaborative Projects".

Applicants should request funds to support any special activities proposed under the Resource Sharing Plan. Sufficient funds can be requested for the curation of a project web site.

PHS 398 Research Plan Component

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

The Research Strategy should include:

The scientific project should describe:

The Project Management Plan should describe:

Description of annual milestones for the scientific project as well as for activities within the GNPN.

A Project Website Plan for construction of the web site for dissemination of research data, software, and other resources of the project. The project website should be linked to a portal webpage of the GNPN and adopt a standard design set by the GNPN Steering Committee.

An agreement to the Cooperative Agreement Terms and Conditions of Award discussed in Section VI.2 and an explanation how the awardee plans to meet these terms and conditions.

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:

There is no prescribed single license for software produced through grants responding to this announcement. However, if software development is planned in the grant application, a software dissemination plan, with appropriate timelines, is expected to be included in the application.

Any software dissemination plan would represent a commitment by the institution (and its subcontractors, if applicable) to support and abide by the plan. The effectiveness of the sharing plans may be evaluated as part of the administrative review of each non-Competing Grant Progress Report.

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.

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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

In order to expedite review, applicants are requested to notify the NIGMS Referral Office by email at sheehyp@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Pre-Application Meeting

The NIGMS will hold a public pre-application meeting for investigators planning to submit applications in response to this FOA no later than 45 days prior to the application submission date. This meeting will be open to the public and will be also available via NIH teleconferencing technologies. Details on the pre-application meeting will be provided on the NIGMS Feedback Loop blog . Participation in the meeting, although encouraged, is optional and not required for application submission.

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.

For this particular announcement, note the following:

The potential to provide impactful transcriptional, translational and functional knowledge, and to deliver game-changing tools, methods and resources in the fields of natural products discovery should be considered a major factor in assessing significance. The medical relevance of the natural products to be discovered should not be a factor in the assessing the significance of the project.

Due to the high risk, high impact and high novelty nature of this FOA, the availability of preliminary data must play a minor role in the evaluation of applications. Major considerations should be placed on the potential to significantly contribute to the current understanding on the function and regulation of biosynthetic operons, and to the development of tools, methods and resources that will highly impact and push forward the field of natural products more than on the likelihood of completion of the project.

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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are expertise in bioinformatics, synthetic biology and natural products described in Section I represented in the project team? Does the management plan satisfactorily address organizational relationships, conflict resolutions' procedures, the process of setting goals and milestones, metrics to measure progress, and sharing of information and resources among team members as described in Section IV.2? Are the plans to meet the project management requirements described in Section IV.2 satisfactory for a productive and effective collaboration among team members? Have the applicants agreed to participate in the GNPN Network as described in the Special Requirements of Section I and are the proposed contributions to the GNPN Network satisfactory to achieve impact on and accelerate the contributions of the project to the GNPN and of the GNPN to the field of natural products?

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? Do the approaches proposed have the potential to deliver game-changing tools, resources and knowledge that will significantly impact the fields of natural products and synthetic biology?  

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? Does the project leverage the genome sequencing data, bioinformatics and synthetic biology tools currently available? Are the approaches proposed high-throughput, broadly applicable and independent of whether the natural product source(s) is cultivable, or the biosynthetic pathways are expressed in the native producer as described in Section I?

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 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 score.

Applications from Foreign Organizations

Not Applicable

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 NIGMS, 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:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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 General Medical Sciences Council. 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

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/PI will have the primary responsibility for:

A substantial commitment (of at least 1.8 person months) is expected for any individual designated as PD/PI on the application. PDs/PIs of the GNPN and funded through this FOA will be required to maintain commitment at least at this minimal level of 1.8 person-month throughout the entire project period.

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

NIH Project Coordinator

The NIH Project Coordinator will be a member of the NIH extramural staff who provides substantial programmatic involvement in the project that is above and beyond normal program stewardship for the "Genomes to Natural Products" awards. The NIH Program Official and the NIH Project Coordinator may not be the same person. The NIH Project Coordinator will be named in the award notice.

The NIH Project Coordinator will:

•   provide technical assistance

•   attend meetings of the project teams

•   provide advice to the PD/PI on policies of the GNPN and the NIH

•   serve as a voting member of the GNPN Steering Committee and attend all meetings

•   make recommendations to the GNPN Steering Committee based upon his/her knowledge of other related NIH-supported research and resource activities

•   facilitate communication between the GNPN to the relevant scientific communities

•   attend the annual meeting of the ESAC, and any (video)conference calls deemed to be necessary

•   provide information to the ESAC on the overall direction of the "Genomes to Natural Products" initiative and on setting and meeting its goals and milestones

•   facilitate interactions among the GNPN Steering Committee, the ESAC and NIH Staff

•   ensure that the ESAC addresses issues and concerns raised by the community

•   advise ways to implement the advice of the ESAC

•   contribute to assessment activities as requested by NIH staff, the ESAC, and other NIH designated evaluation groups

•   report to NIGMS Council on the progress of the "Genomes to Natural Products" initiative as needed

•   take on additional responsibilities as negotiated at the time of the award.

NIH Program Official

The NIH Program Official will be a member of the NIH extramural staff who will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIH Program Official and the NIH Project Coordinator may not be the same person.

The NIH Program Official will:

•   attend peer review and NIGMS Advisory Council and make funding recommendations to NIGMS Director

•   negotiate and approve goals, milestones and resource sharing plans with the awardees

•   recommend appropriate budgets for the research project, including withholding or reduction of support for failure to meet milestones and/or other terms or conditions

•   appoint the Chair of the GNPN Steering Committee after receiving nomination by the GNPN Steering Committee

•   approve for membership to the GNPN Steering Committee the one non-voting representative of the affiliate members nominated by the GNPN Steering Committee. These members will have to adhere to the policies and the resource and material sharing plans of the GNPN.

•   evaluate progress of the awarded projects

Milestones and Goals

Appropriate goals and annual milestones for each components of the GNPN will be set to ensure that the overall goals of the initiative are met. Initial annual milestones are reported in the application and further negotiated between the applicant and the NIH Program Official assigned to the application during the award process. The annual milestones will be included in the Terms and Conditions of Award. Milestones will be further refined as the "Genomes to Natural Products" initiatives evolves with input from the GNPN Steering Committee and renegotiated annually as part of the non-competing continuation award process. The NIH may reduce or withhold funds for failure to meet milestones agreed upon by the investigators and NIH staff.

Data Sharing

The resources generated by the research should be easily accessible as described in Section IV.2 under "Resource Sharing Plan" consistent with achieving the goals of the program.  Sharing is expected to be nonexclusive access, timely and responsible release, and reasonable accommodation. To implement these principles, the PD(s)/PI(s) working with the GNPN Steering Committee and the Project Coordinator will develop operating rules and guidelines that are beyond those specified in the application or agreed upon at the time of award. The milestones and management should reflect an appropriate balance between responsible validation and a prompt timetable for evaluation and release. In seeking this equitable balance, the interests of the field and the community as a whole (as opposed to individuals) should be a leading consideration. All resources generated will be described in academic publications, and the Institutions should honor reasonable requests for such materials from third parties. Where private sector involvement is desirable to assist with maintenance, reproduction, and/or distribution of the resources, or because further research and development are needed to realize the invention's usefulness as a research tool, licenses should be crafted to fit the circumstances, with the goal of ensuring widespread and appropriate distribution of the final tool product to the research community. Members of the GNPN Network should be given minimal cost access to the products. Software generated should be free of charge to the non-profit research community.

Non-exclusive access

Resources derived from this FOA should be easily accessible to other members of the GNPN, to non-participating researchers and the public. Materials are expected to be available to the entire community (not just Network members) without restrictions for research purposes to the extent that it is reasonable within NIH guidelines and without significantly affecting the progress of the project. All Institutions should receive a non-exclusive, royalty-free license to use all research tools, biological materials, source code to copyrightable software, and patent rights (collectively, IP) developed under the GNPN for academic research and teaching purposes.

Once the information is referenced in any research article, it is expected to be immediately released to the entire community without restrictions. Once a resource is referenced in any research article that draws conclusions from its use, it is expected to be immediately released to the entire scientific community without restrictions. Resources prior to publication should be shared within the GNPN following the rules and guidelines established by the GNPN Steering Committee.

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 GNPN 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 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)

Dr. Barbara Gerratana
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3827
Email: gerratanab@mail.nih.gov

Peer Review Contact(s)

Helen R. Sunshine, Ph.D.
Chief, Office of Scientific Review
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-2881
Email: sunshinh@nigms.nih.gov

Financial/Grants Management Contact(s)

Ms. Lisa Moeller
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3914
Email: moellerl@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.


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