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.

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

This funding opportunity announcement (FOA) offers support for a high impact pharmacogenomics knowledge base as a research resource available to the entire scientific community. There is an existing Pharmacogenomics Knowledge Base, PharmGKB, and it is the intention of NIGMS to continue one knowledge base. This is an open competition and any qualified applicants are invited to respond. Advance consultation with Scientific/Research staff to ensure that a proposed resource fits well with this opportunity is highly encouraged.

Pharmacogenomics is the science of predicting drug responses from genomic sequence information, part of the field of precision medicine. The mission of the Pharmacogenomics Knowledge Base (PharmGKB) is the collection and dissemination of knowledge about the role of human genomic variation in drug responses, curation and description of genotype and phenotype associations, annotation of genetic variants and connection with drug effects, identification of very important pharmacogenes supported by literature evidence, display of known drug-gene relationships and pathways, and facilitation of innovative computational efforts designed to accelerate new research discoveries and clinical implementation of those research discoveries.

PharmGKB has been funded since 2000 by NIGMS and other institutes of the NIH, as a partner with the Pharmacogenomics Research Network (PGRN). The knowledge base has been an important contributor of highly curated, trustworthy information for the field. In addition, it has catalyzed the formation of very successful important community-driven activities based upon pharmacogenomics knowledge, such as the Clinical Implementation Pharmacogenetics Consortium (CPIC) and the Drug-specific Consortia in Pharmacogenomics (e.g., IWPC, ISPC, ICPC, ITPC, CAPS, GEMS). Now that they are established, the institute wants to "spin off" those activities as independent, self-supporting, and in some cases time-limited resources, in order to allow PharmGKB to develop entirely new innovative ways to serve the collective needs of investigators in pharmacogenomics.

Acting on the advice of the National Advisory General Medical Sciences Council, following discussion at its meeting in Fall 2013, selected funding opportunities are being offered in a transition plan for the PGRN as part of a program for Pharmacogenomics in Precision Medicine. If a successful application for a knowledge base is presented, NIGMS envisions that PharmGKB will continue to interact with the PGRN of the future, beginning in 2015. The network, together with the knowledge base, should lead information exchange and problem-solving in the field.

The Advisory Council also recommended that NIGMS strengthen its commitment to diversity across all of its program areas and funding opportunities. Therefore, applicants for this FOA are strongly encouraged to identify creative ways to encourage the participation of individuals from diverse backgrounds underrepresented in biomedical research in the development of knowledge generated under this program, and in the dissemination of that information to institutions and investigators who serve underrepresented populations.

PharmGKB should be a forefront resource that curates knowledge about the impact of genomic variation and its sequelae on the prediction of drug responses for researchers and clinicians. It is expected to offer the most modern and efficient approaches to presenting data, tools, information, and services essential to making timely, high quality, and cost-efficient progress in the field. An evolving knowledge base will apply state-of-the-art computational methodologies to high level problems in pharmacogenomics in ways that broadly based databases cannot accomplish.

PharmGKB should be sufficiently specialized to spur the solution of modern research problems at the interface of drugs, genomes, and diseases. It should also buttress efforts funded by other NIH initiatives designed to achieve genomic medicine, specifically for the domain of pharmacogenomics. The knowledge base should substantially accelerate progress in the field enabling new original scientific discoveries and translation for pharmacogenomics in precision medicine.

The primary purpose of PharmGKB continues to be to present knowledge. Moreover, the body of knowledge to be represented is constantly growing. PharmGKB must be poised to move from individual analysis of genes, drugs, and pathways towards developing and applying knowledge in new and larger throughput ways. PharmGKB is not intended to be a comprehensive data repository. The resource should judiciously choose what to store and how to operate on data to advance pharmacogenomics knowledge.

PharmGKB should have significant content that is well-curated, stable, and routinely updated. In addition, as the volume of knowledge is rapidly growing in scale, with a greater variety of data types, the knowledge base should make the leap from the gold standard of human-curated information to the delivery of predictions derived from data mining approaches. It should also offer innovative computational tools that aid in accomplishing its mission (e.g., to interpret complete genome sequences for drug responses). PharmGKB should be evolving as the field moves toward precision (or data-driven ) medicine.

Features utilized by the knowledge base are expected to include, but are not limited to:

• utilizing standardized nomenclature for the most relevant genes, drug names, and diseases;
• offering structured formats for drug-gene-disease knowledge relationships;
• using complete drug response ontologies suitable for mapping and analysis;
• presenting the wide range of variation in the genome for pharmacogenomic genes;
• annotating variants of potential significance in innovative automated ways;
• visualization of larger-scale pharmacogenomics data sets and information;
• integrating disparate data types (e.g., reflecting phenotypes) important for drug responses;
• developing algorithms that can extract pharmacogenomic knowledge from large data sets;
• creating new tools to support the design of future pharmacogenomics research studies;
• utilizing interoperability standards according to most appropriate benchmarks in the field;
• interrelating with other established high quality and trusted repositories;
• promoting efficient downloadability of very large and complex data sets in modern formats;
• delivering data compatible with the most useful systems biology modeling languages;
• employing modern web interface design that is user-friendly, browseable and interactive;
• transparently sharing procedures for curation, both human- and machine-based;
• providing significant added value over the published literature in pharmacogenomics.

Where novel methods and approaches are developed, PharmGKB should publish its own original work in peer-reviewed journals. PharmGKB may conduct limited research, in pursuit of the goal of serving as a resource for the field of pharmacogenomics in precision medicine. The knowledge base should also offer education and outreach activities, so that potential users can learn of the resource.

PharmGKB should aid in making research discoveries and implementing research discoveries of known clinical utility. The knowledge base should interact meaningfully with other NIH-supported comprehensive community-serving efforts (e.g., Genetic Testing Registry (GTR), the Clinical Genome Resource (ClinGen), and others) that disseminate information regarding established relationships between genes, variants, drugs, diseases, and pathways in pharmacogenomics.

As a research resource, PharmGKB should anticipate the obstacles and support the culture of data sharing. For example, methods, analysis tools, data summaries and other metadata should be made widely available to the scientific public. Additionally, data transfer policies and standard methods for downloading data should be shared on the website. Consistent with the goals of the program, all data types are expected to be shared as soon as is reasonably possible utilizing the most current best practice approaches. For example, software should be distributed and maintained with open source licensing agreements. All users of PharmGKB must be allowed to download complete data sets and knowledge relationships for research purposes.

The name PharmGKB is trademarked by NIGMS at NIH, and the existing web-based content structure and visual display of the current knowledge base contents are copyright-protected by Stanford University. Licensing agreements must ensure free usage for research purposes; agreements may limit repackaging and/or redistribution of contents according to policies developed by the technology transfer office of the awarded site.

The portability of PharmGKB data sets and related knowledge content should be ensured at all times. All of the data in PharmGKB are presently available to registered users for downloading by standard formats. If a new knowledge base award is funded, copies of the existing data contents and tables will be provided at the time of award, according to the existing agreement regarding data portability.

As a research resource, PharmGKB should clearly identify the anticipated user communities and the broad collective characteristics of its members (e.g., educational background, type of organizational affiliation, purpose for accessing the knowledge base). PharmGKB should establish and utilize a Scientific Advisory Committee to aid in this goal. With these communities in mind, the knowledge base should include processes to monitor data access and the uptake of knowledge and tools offered at the website, and regularly seek to develop improved ways to serve its end users.

Plans to evaluate service utilization should be built-in. Routine measures to monitor performance as short-term internal process metrics (for utilization and ongoing improvement) and as long-term metrics (to objectively determine the extent of impact on the field) are essential. These measures are important for assessing the operating success and ultimate significance of PharmGKB for accelerating progress for pharmacogenomics in precision medicine.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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.

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

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:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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.

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.

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

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

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

The letter of intent should be sent to:

Rochelle M. Long, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3827
Fax: 301-480-2802
Email: rochelle.long@nih.gov

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

The forms package associated with this FOA includes all applicable components, required 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.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

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

Specific Aims: Provide a succinct description of the knowledge base's overall goals and expected outcomes, and the impact should those goals be achieved. The specific aims should support the purpose to offer a high-impact knowledge base for pharmacogenomics.

Research Strategy: Provide a description of the overall plans for the knowledge base and explain how they address NIGMS' objective to provide a forefront resource that curates knowledge about the impact of genomic variation on the prediction of drug responses for researchers and clinicians. Report on preliminary studies, if this is a new application; report on progress made to date, if this is a renewal application. Explain the approaches and how they will maintain highly curated, trustworthy content and also apply state-of-the-art computational methods to develop new information useful to solve high level problems in pharmacogenomics.

Include well described plans for evaluation. As part of this program, processes to monitor access and uptake of the knowledge should be built-in. This includes routine measures to monitor performance as short-term internal process metrics for utilization and ongoing improvement, and as long-term metrics to objectively determine the extent of impact on the field. PharmGKB should establish a Scientific Advisory Committee that meets periodically (e.g., annually) to aid in fulfilling the objective of this program to create a valuable resource that is appropriately utilized by its targeted users.

Letters of Support: A strong commitment by any collaborators or knowledge base partners (e.g., other community-serving efforts) is required. This should be stated in letters describing the specific contributions, access, data, or other efforts. However, general letters of support from individuals, user groups, future advisors, or other scientifically related networks who will not be substantially involved should NOT be provided, because this complicates the review of an application. Documentation should only be from those named in the application (e.g., required collaborators, significant partners) who are expected to contribute in a substantive way to the proposed resource. The requested letter(s) should be submitted as an attachment in the Letters of Support field on the Research Plan form. All letters should be concatenated into a single PDF attachment.

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:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Consistent with achieving the goals of the program, applicants should specifically address how data (including methods, analysis tools, data summaries, metadata and other information types) will be made widely available to the scientific public. Software should be distributed and maintained according to open license standards. All users of PharmGKB must be allowed to download the complete knowledge base contents, including data sets and knowledge relationships, for research purposes, as promptly as reasonably possible.

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.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date 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.

This initiative is not subject to intergovernmental review.

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.

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. See Section III of this FOA for information on registration requirements.

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. 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 paul.sheehy@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

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).

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?

Additionally, how well does the knowledge base identify its users, their needs, and how will it serve those communities in substantive ways that justify having a specialized resource? How will it provide the most modern and efficient approaches to presenting data, tools, information, and services essential to making timely, high quality, and cost-efficient progress in the 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?

Additionally, how is the leadership team optimized to successfully accomplish and manage this knowledge base resource?

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?

Additionally, how does the knowledge base propose entirely new innovative ways to serve the collective needs of investigators in pharmacogenomics?

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?

Additionally, how will the proposed knowledge base resource evolve in its computational methodologies? Will the approaches aid in finding solutions to high-level problems in pharmacogenomics in ways that broadly based databases cannot accomplish? Are evaluation processes built-in so that the resource will routinely seek to develop improved ways to serve its end users? Is the knowledge base state-of-the-art for the field?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion 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?

Additionally, is the knowledge base positioned so that it can leverage other ongoing community-serving projects in pharmacogenomics?

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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

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

Revisions

Not Applicable

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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

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 submitted in response to this FOA. 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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Program continuity.

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.

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.

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

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.

Other Reporting Requirements: Consistent with achieving the goals of this program, the awardee will be required to report annually on the results of the ongoing evaluation efforts (described by the applicant in the Research Plans), and on the recommendations of the Scientific Advisory Committee convened by the grantee. This information may be included in the annual progress reports submitted to NIH.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: http://grants.nih.gov/support/index.html

TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Rochelle Long, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3827
Email: rochelle.long@nih.gov

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

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

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.

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.