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 initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.

"Accelerating Translation of Glycoscience: Integration and Accessibility" is an NIH Common Fund program designed to support the development of accessible and affordable new tools and technologies for studying carbohydrates that will enable researchers in all biomedical fields to dramatically advance our understanding of the roles of these complex molecules in health and disease and to not abandon carbohydrate-related research challenges due to the lack of accessible tools.

Carbohydrates (or glycans) are ubiquitous and play roles in a wide range of biological functions and disease processes. Nearly all aspects of biology, including: a) protein folding; b) cell adhesion and trafficking; c) cell signaling, fertilization and embryogenesis; and d) pathogen recognition and immune responses (both innate and adaptive) are affected by glycan-mediated events. However, the complexity of carbohydrates, which is increased by the presence of stereo-isomers, anomeric configurations, branch chains, and modifications such as sulfation, methylation, and phosphorylation, render study of the biological roles of glycans inaccessible to most biomedical researchers. Compared to genomics and protein biochemistry, glycoscience suffers from the inability to carry out high throughput synthesis or structural and functional analysis of glycans. The structural complexity of carbohydrates creates a difficult problem for data analysis, representation, and sharing.

A primary roadblock preventing study of the roles of carbohydrates in most biological and disease pathways remains the limited availability of robust, affordable, and accessible tools and technologies that can be used by non-specialists to decipher the biochemical basis of glycan protein and glycan-lipid interactions, and integrate this information with other platforms. Currently, the synthesis of carbohydrates and analysis of glycans and their binding proteins are carried out by a small cadre of highly specialized investigators with the requisite knowledge and sophisticated resources to perform these tasks. Analysis of glycan structure is hampered by a lack of glycan standards, including sets of isomers and related compounds with features that would mimic the breadth of glycan diversity found in biological samples. Straightforward and accessible methods for identifying the carbohydrates that are attached to glycoproteins or glycolipids are not currently available, nor are techniques for determining the specificity of carbohydrate-binding proteins. Additionally, data generated from research on glycans and their binding proteins are not well-integrated with existing gene and protein databases. Therefore, attempts to complement gene and protein data with relevant glycan information are often frustrating, especially for those who are not glycoscience specialists.

The development of accessible informatics technologies for analysis and integration of carbohydrate and glycoconjugate data will require the participation of many independent research groups. This FOA solicits applications for planning grants that will identify the time and resources needed to organize an inclusive, community-driven project that can provide a framework for integration of carbohydrate and glycoconjugate structural, analytical, and functional data. This project must reach beyond the glycoinformatics community to integrate carbohydrate data with comparable gene and protein data.

A subsequent FOA will invite applications for full support of this project, through a single award, administered as a cooperative agreement. It is expected that the recipients of planning grants will work collaboratively to develop a plan for glycoinformatics data integration and technology development. As far as possible, the technologies developed should enable integration of existing glycoinformatic databases, and create a well-characterized, stable, flexible context for future development of interoperable glycoinformatics technologies and databases.

Integration of glycoinformatics with protein and gene databases is a fundamental goal of this program. Glycan and glycoconjugate synthesis is not template driven. Complex networks govern the biosynthesis, structure and function of these molecules, and their effects are similarly diverse and subtle. The biochemistry of carbohydrates cannot be studied in isolation. Informatics tools that can integrate carbohydrate information into the larger context of biological systems are essential to understand either glycosylation or those systems.

Glycan and glycoconjugate experimental data need to be interpreted and integrated in order to meaningfully incorporate that information into the larger context of biomedical research. Glycoinformatics technologies for the interpretation, mining, annotation, and sharing of data are sparse and poorly integrated. Significant data analysis needs in this field include, but are not limited to:

- Minimal standards for reporting metadata associated with experimental results

- Standards for representation and identifiers of carbohydrate and glycoconjugate structures that account for ambiguities inherent in glycan structure determination

- A common ontology for contextualization of data and information on glycan and glycoconjugate structure, function, etc.

- Assignment of structures from analytical data

- Assignment of glycans with linkages, to protein/lipid attachment sites

- Visualization of complex datasets from multiple platforms

- Simultaneous mining of glycan structure, glycan array binding, gene expression, and other related data

Projects proposed under this program should expand the useable knowledge base of biomedical research through the development of improved tools for analysis and representation of glycan data and the integration of that data across the glycoscience field and with other relevant databases outside the field. Ideally, a contextual framework will be established that enables the transparent integration of existing glycoinformatics databases of varying degrees of specialization, and establishes parameters that can inform future database development. This framework should enable new tools, as they are developed, to access those databases.

Awards made under this FOA will support all research planning activities, including, but not limited to:

• establishment of the research team

• identification of collaborators (both domestic and foreign collaborations are encouraged)

• design of the full project

• development of milestones for the full project

• development of a detailed budget for the full project

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 - NIH Intramural Program

• 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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept 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, including Supplemental Grant Application Instructions 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:

Douglas M. Sheeley, Sc.D.
National Institute of General Medical Sciences (NIGMS)

Telephone: 301-451-6446

Email: [email protected]

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

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.

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

Research Strategy: As part of the Research Strategy Section, applications should clearly address the following aspects:

1) This initiative will support planning grants. Specific plans should be presented for formation of research teams and interaction with other researchers in the field. Plans for preliminary research to develop the basic framework of the approach to be proposed in a subsequent full application should be described.

2) Active engagement of the broad glycoscience and glycoinformatics communities is expected. Technologies and data standards developed in this program will have to be supported and widely adopted by the user community in order to be useful. Applicants should describe the approaches that will be taken to ensure, to the extent reasonably possible, the development of broadly applicable, consensus-driven solutions.

3) This program is focused on creating new methods and resources that can be more easily understood and accessed by the broader biomedical research community. Plans should be presented for preparation of training resources to support access to the tools being developed.

4) Integration and Accessibility: A primary roadblock preventing the study of the roles of carbohydrates in most biological and disease pathways remains the limited availability of affordable and accessible tools and technologies that can be used by non-specialists. As such, applications must address how their proposed resource will make glycoscience more "integrated and accessible" by addressing these working definitions:

• Less complex: e.g. requires fewer steps; easier specimen preparation; does not involve hard to access or expensive equipment; or develops ready-to-use assemblies that will easily interface with existing technologies.

• Easily available and affordable: e.g. enables researcher to perform the process using standard lab equipment and reagents; creation of off-the-shelf kits or assays; and/or development of new, faster, less expensive technology.

• Easy to understand and adapt to different systems: e.g. training on proper use of the methods, tools, or technologies being developed; providing the user with relevant background information on use of the new resource within the broader context of glycobiology; addressing how resources being developed would improve upon existing resources, tools, and/or data sources.

5) Project Milestones: Applications must provide milestones of project progress along with a timeline to completion.

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.

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.

Applications Involving the NIH Intramural Research Program