It is critical that applicants follow the instructions in the Research Instructions for 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 allow biomedical researchers to significantly advance our understanding of the roles of these complex molecules in health and disease. This program will enable investigators who might not otherwise conduct research in the glycosciences, to undertake the study of carbohydrate structure and function.

Investigators funded through awards under this FOA and the companion FOAs, as well as appropriate NIH staff, will constitute the Glycoscience Consortium. It is expected that scientists funded through the Common Fund Glycoscience program will work cooperatively.

Carbohydrates (or glycans) are ubiquitous and play a role 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 amplified by the presence of stereo-isomers, anomeric configurations, branched chains, and modifications such as sulfation, methylation, and phosphorylation, render study of the biological roles of glycans intractable 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 difficult problems for data analysis, representation, and sharing.

A primary roadblock hindering 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 sophisticated, expensive, analytical equipment 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 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 readily 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 analysis and integration of carbohydrate and glycoconjugate data is a complex challenge. Present computational and informatics technologies for carbohydrate analysis are decades behind those developed for nucleic acids and proteins. Like other aspects of glycobiology, progress in glycoinformatics is sporadic and fragmented. The resulting tools are primitive, and poorly integrated, and adoption by non-specialists has been slow. Certain glycoinformatics tools, such as glycan structure databases, have been developed. These databases, however, are limited and balkanized, and are not matched with tools for interrogating the databases in meaningful ways. They are also not well-integrated with databases for proteins or genomic information. Other classes of glycoinformatics tools are in their infancy, or entirely lacking. Examples include algorithms for spectral interpretation to support glycoconjugate structure determination, or interpretation of glycan array binding data.

Recent community-led efforts to arrive at standardization of glycan nomenclature as expressed in databases, interoperability of databases, and reporting of experimental metadata have been promising. Two important features of these recent efforts are: (1) they have been inclusive, community-driven projects, and (2) they have focused on preserving the utility of the tools already created. Efforts to bring glycoinformatics up to the current state of the art available for the other classes of biological macromolecules must be grounded in a clearly articulated vision for addressing the significant challenges confronting the field, and facilitate participation of many independent research groups. The project should create an environment that enables current and future software developers to join this effort with a clear understanding of the framework within which their contributions will be most effective.

This FOA follows on from RFA-RM-14-012, which solicited applications for planning grants to 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. That FOA stated that the resulting project must reach beyond the glycoinformatics community to integrate carbohydrate data with comparable gene and protein data. It was expected that the recipients of planning grants would work collaboratively to develop a plan for glycoinformatics data integration and technology development that would enable integration of existing glycoinformatic databases, and create a well-characterized, stable, flexible context for future development of interoperable glycoinformatics technologies and databases. This FOA now invites applications for full support of such a project, through a single award, administered as a cooperative agreement. This FOA is an open competition, not limited to planning grant recipients. However, the same expectations of inclusiveness and integration apply in this context.

The fundamental goal of this program is the integration of glycoinformatics with protein and gene data and databases. Glycoinformatics technologies for the interpretation, mining, annotation, and sharing of data are sparse and poorly integrated. Informatics tools that can integrate carbohydrate information into the larger context of biological systems are essential to understanding both glycosylation and the biological systems involved. Significant data analysis and integration needs in this field include, but are not limited to:

• Technologies for data processing and analysis
• Assignment of structures from analytical data
• Assignment of glycans with linkages, to protein/lipid attachment sites
• Standards for representation and identifiers of carbohydrate and glycoconjugate structures that account for ambiguities inherent in glycan structure determination
• Minimal standards for reporting metadata associated with experimental results
• A common ontology for contextualization of data and information on glycan and glycoconjugate structure, function, etc.
• 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. Special attention should be given to ensuring that technologies developed are accessible to non-specialists.

Applications under this program will inevitably seek support to develop new software, as well as adapting and improving existing software. A number of anticipated features of such software are listed below. Any of these improvements should benefit the existing user community, but more importantly, have strong potential to attract more users, particularly those outside the core glycobiology community.

Contemporary software must be easy to modify and extend, and must be fully documented. Users who experience problems with software should be able to correct the problem with minimal effort and a mechanism must exist for incorporating these corrections into the software. As the needs of a community of users change, the software that supports their research efforts must be adaptable as well. The ability of software to be repaired and to evolve is particularly important.

Interoperability among different software packages or among software and existing databases is a major challenge. Applications under this FOA should extend interoperability, as well as building a framework for future development, beyond the end of the program, in which modular software components can be developed and modified as the glycoscience field evolves. To the extent possible, consideration should be given to developing and adapting software so that it operates on a variety of platforms employing different operating systems.

Finally, the goals of this program are consistent with those of NIH BD2K and BISTI Initiatives, to promote a culture where a large body of annotated and shareable data is available online to the broad biomedical research community. The development and use of data and metadata standards are critical for achieving this goal. The NIH has a number of efforts to stimulate the creation and support of community-based approaches to develop such standards. Investigators may participate in the development of data standards, and may serve as early testers and adopters of community-developed standards.

See Section VIII. Other Information for award authorities and regulations.

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the instructions in the Research Instructions for 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.
Telephone: 301-451-6446
Fax: 301-480-2802
Email: sheeleyd@mail.nih.gov

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 along with the following additional budget-related information:

• Applicants must budget funds for travel for at least one PD/PI to attend an annual meeting of the Common Fund Glycoscience investigators each year.

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) The overall framework and rationale for the proposed approach to the project should be described. This should include an explanation of the specific glycoinformatics needs in the community, and why the proposed plan will address those needs. Include plans for the formation of the research team, as well as plans for interaction with and inclusion of other researchers in the field.

2) Active participation of the glycoscience and glycoinformatics communities, as well as engagement of the broader scientific community are 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 that can be integrated with protein, lipid, and gene data and databases.

The application should include a plan for how the proposed U01 will manage data and metadata standards and formats. Applicants should, as appropriate, i) engage with community-based standard and format development activities, and ii) apply community-based standards and formats to the data and metadata for which the U01 is developing tools.

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. A milestone is a defined event, achievement, or important stage that is used to indicate the progress of a project. Milestones should be descriptive of what will be done and when it will be completed.

Scientific Validation: Each application should contain a brief plan for validation of the scientific software, tools and related resources. This plan should provide the organizing principles by which scientific validation will be conducted.

User input: Projects should include plans for how end user input will be obtained. Users may be basic or translational biomedical researchers, experimental scientists, software developers, or computational scientists.

Because this project will be pursued within the context of the Common Fund Glycoscience Consortium, which encourages collaboration among participating investigators, applicants are encouraged to consider taking advantage of access to early adopters within the program for early-stage validation and user input.

Evaluation: The application should include a plan for evaluating the quality and utility of the new software, tools and related resources being developed through this initiative. Criteria for evaluation of products may include adequacy, trustworthiness, authenticity, integrity, availability, documentation, and transparency. Specific examples of evaluative information could include, as appropriate, the quality of publications citing uses, tracking the number of users, background/training of the users, requests for services, successful use of the products, number of students, use of training materials, the ability to extend the utility of tools through collaborations with other investigators, etc. The research community being served will have expectations that could be documented through mechanisms such as user feedback, letters of support, etc. Quantifiable measures of results and success are important and should be built in as:

• Short-term internal metrics (for ongoing improvement);
• Long-term objective metrics (to gauge impact of use on the scientific field).

Methods for assessment, such as user registration, should not be so onerous that they compromise the use of the investigator’s resources.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans 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.

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

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

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

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

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

5. To further enhance the potential impact of their software, applicants may consider proposing a plan to manage and disseminate the improvements or customizations of their tools and resources by others. This application for funding may include a plan to incorporate the enhancements into the official core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution. Accordingly, awardees are encouraged to manage and disseminate their source code through an open revision control and source code management system such as GitHub.

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 PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

NIH encourages the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PD/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.

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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Are the 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?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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?

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?

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.

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. Reviewers will assess whether the application would make glycoscience more "integrated and accessible" by considering the following aspects:

Less complex: Would the application, for example, reduce the number of steps; make specimen preparation easier; or develop ready-to-use assemblies that will easily interface with existing technologies?

Easily available and affordable: Would the application, for example, enable researchers to perform the process using standard lab equipment and reagents; create off-the-shelf kits or assays; and/or result in the development of new, faster, less expensive technology?

Easy to understand and adapt to different systems: Would the application, for example, provide training on proper use of the methods, tools, or technologies being developed; provide the user with relevant background information on use of the new resource within the broader context of glycobiology; and/or improve upon existing resources, tools, or data sources?

Project Milestones

Does the application include appropriate milestones of project progress and a timeline? Are the milestones clearly defined and achievable? Is the timeline realistic?

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.

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.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

Not Applicable

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.

Not Applicable

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).

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) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 the Center for Scientific Review (CSR), 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 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.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this 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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 Part 75, 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(s)/PI(s) Authorities and Responsibilities:

The Program Director(s)/Principal Investigator(s) will have the primary responsibility for defining the details for the projects within the guidelines of this FOA and for performing all scientific activities. The PD/PI will agree to accept the close coordination, cooperation, and participation of the NIH staff (Project Scientists and other appropriate Glycoscience Program Staff) in those aspects of scientific and technical management of the projects as described below. Specifically, the PD/PI supported by this Glycoscience Program award will:

• Retain the primary authority and responsibility for the project as a whole, including defining the research objectives, conducting specific studies, analysis and interpretation of research data, and preparation of publications.
• Provide, in addition to standard annual progress reports (see Section VI.3. Reporting), other relevant information to the NIH Project Scientist or Program Officer, and coordinate and cooperate with NIH staff and other members of appropriate collaborating NIH programs.
• Be expected to work directly with the NIH Project Scientist on the coordination of intra-program activities, the scientific integration of individual projects within the Glycoscience Consortium, and implementation of individual project cross-validation.
• Join the Glycoscience Consortium, participate in person, and budget for travel to joint meetings held once annually at the NIH.
• Participate in the appropriate coordinating meetings and/or working groups, and/or teleconferences as needed.
• Agree not to disclose confidential information obtained from other members of the Glycoscience Consortium and extended network.
• Accept and implement all scientific, practical and policy decisions approved by the Glycoscience Consortium in addition to applicable NIH policies, laws, and regulations.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

A designated NIH Program Staff member, acting as Project Scientist, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The role of the Project Scientist will be to facilitate and not to direct. This includes facilitating the partnership relationship between NIH, the Glycoscience Consortium, and the awardees. The Project Scientist’s role includes helping to maintain the overall scientific balance in the program commensurate with new research and emerging research opportunities, facilitating communication and coordination among the awardees, and ensuring that the activities of the awardees are consistent with the mission of Accelerating Translation of Glycoscience: Integration and Accessibility. Specifically, the NIH Project Scientist will:

• Provide technical assistance and advice to the individual Glycoscience awardee as appropriate to achieve the aims of the cooperative agreement.
• Work directly with the awardee to facilitate their collaborations with other awardees.
• Coordinate and facilitate the interactions among the Glycoscience awardees.
• Promote and help coordinate collaborative research efforts that involve interactions with other members of the Glycoscience Consortium, as well as with other NIH-sponsored programs, projects, and centers where appropriate.
• Assist in the interaction between the awardee and other investigators, as appropriate for the program.
• Assist in the interaction and collaboration between awardees and potential commercial partners.
• Assist in avoiding unwarranted duplication of effort.

To help carry out these duties, Project Scientists may consult with experts in the field.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The Program Officer may have substantial programmatic involvement to coordinate and facilitate collaborations with other awardees and ensure the activities of the project are consistent with Accelerating Translation of Glycoscience: Integration and Accessibility and the goals of this FOA. The Program Officer may be the same person as Project Scientist, in which case, the individual involved will not attend peer review meetings, or will seek NIH waiver according to the NIH procedures for management of conflict of interest.

The NIH Program Officer(s) may solicit the opinions of External Consultants who are senior non-federal scientists not directly involved in the activities of the Glycoscience Initiative. The ESE’s would serve as consultants, who would individually advise NIH on the progress of the Glycoscience Program, on the contributions of individual projects and/or project collaborations within the consortium, and on the progress and effectiveness of the consortium as a whole.

Areas of Joint Responsibility:

The NIH Project Scientist(s) and the PDs/PIs of the Glycoscience Program will be jointly responsible for the coordination of intra-program activities and the scientific integration of individual projects with other appropriate NIH programs. Joint responsibilities include:

• Developing working groups and trans-project efforts as needed.
• Organizing and conducting regular meetings to share progress and foster collaborations between the awardees, either by teleconference, videoconference, or face-to-face, as needed.

Although the Glycoscience Program will not have any separate formal governing body, the awardees' activities may involve the formation of a Coordinating Group. The primary role of the Coordinating Group will be to serve as an interface between the individual projects funded under this FOA and appropriate NIH programs. Such a Coordinating Group, if formed, will:

• Consist of the PD/PI and the NIH Project Scientist from each project.
• Convene to assess scientific progress, identify new research opportunities, establish priorities, consider policy recommendations, propose publication guidelines and discuss strategies.
• Meet in person, virtual, or by teleconference, with additional project staff and/or NIH staff, as needed.
• The NIH Project Scientist(s) will initiate the formation of the Coordinating Group and will facilitate its activities.

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: one selected by the Coordinating Group (with the NIH members not voting) or by the individual awardee in the event of an individual disagreement, 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.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 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)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Douglas M. Sheeley, Sc.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-6446
Email: sheeleyd@mail.nih.gov

J. Thomas Peterson, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-408-9694
Email: petersonjt@csr.nih.gov

Lisa Moeller, CRA
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3914
Email: Lm236j@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 Part 75.