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 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 anticipated 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.

Research Objectives and Scope

At present, methods exist to synthesize only a small portion of the human and/or other biomedically relevant mammalian and microbial glycomes and these methodologies are generally complex, producing limited quantities of defined glycans/glycoconjugates at considerable cost. The lack of approaches and technologies to produce affordable, well-characterized glycans and glycoconjugates that span the chemical diversity of mammalian and microbial glycomes has severely hampered efforts to develop tools to decipher the functions of glycans in normal and disease processes, and resulted in a paucity of standards for use in determining the structure of glycans. Ideally, one would like to be able to efficiently and cost effectively synthesize all the glycans/glycoconjugates that compose bio-medically relevant mammalian and microbial glycomes at will, and to be able to scale up synthesis when appropriate. This FOA therefore solicits applications to develop new innovative methods (catalytic, chemical, and/or chemo-enzymatic), and technologies to facilitate the rapid, robust, and affordable synthesis, and/or functionalization of the bio-medically relevant glycans and glycoconjugates that span the chemical diversity of mammalian and microbial glycomes. Synthetic approaches may be chemical and/or chemo-enzymatic and should be scalable to sufficient quantity and purity to facilitate development of robust carbohydrate libraries, structural standards, and/or specialized reagents necessary for deciphering the roles of glycans/glycoconjugates in both normal and disease processes. New robust, stereo-selective catalytic methods; approaches that open up new chemical space; and approaches amenable to, and/or technologies that facilitate automation of carbohydrate synthesis are especially sought. Choice of synthetic targets should be well justified based on their relevance to human health. As applicable, efforts must consider factors for scale-up and efforts to make any instrumentation developed broadly accessible and cost-effective for the end-user. For approaches and technologies developed under this FOA, detailed synthetic protocols and documentation verifying the purity and structures of synthetic products will ultimately need to be provided in order to facilitate cross validation, as required for this Common Fund effort.

Specific Areas of Research Interest

This FOA is focused on two areas: 1) development of new methods and technologies for synthesis of biomedically relevant mammalian glycomes; and 2) development of new methods and technologies for synthesis of biomedically relevant microbial glycans that can inform on disease processes.

Examples of applications responsive to this FOA would include but are not limited to:

• New facile strategies for the synthesis and production of biomedically relevant and homogeneous glycans, glycopeptides, glycoproteins, glycolipids, glycosaminoglycans/proteoglycans, or microbial polysaccharides and glycoconjugates;
• New chemical and/or chemo-enzymatic strategies for facile, cost effective synthesis and scalable production of uniform batches (tetra-saccharides or greater, where the glycan structure is well-defined), of glycans, glycopeptides, glycoproteins, glycolipids, glycosaminoglycans/proteoglycans, or microbial polysaccharides and glycoconjugates, in at least milligram quantity for use as standards, or in tool development;
• New chemical and/or chemo-enzymatic strategies for facile, cost effective synthesis and scalable production of complex carbohydrates, including multiantennary and asymmetrically branched glycans;
• New catalytic strategies for stereo-selective glycosylation and production of sets of isomeric structures that differ in topology, linkage, and anomeric configuration.
• New chemical and/or chemo-enzymatic strategies for facile, cost effective synthesis and scalable production of complex carbohydrates, that include modifications (e.g., acetyl, sulfate groups, sialic acid diversity);
• New, facile, cost-effective strategies for automated synthesis of homogeneous carbohydrates and/or glycoconjugates;
• New facile, cost-effective strategies for synthesis of carbohydrate structures with isotopic enrichment of specific desired atoms;
• New facile and cost-effective strategies for conjugating or linking glycans to selected sites on proteins, and/or lipids;
• New facile, cost-effective strategies for synthesis of: sugar nucleotide derivatives, or saccharide building blocks for synthesis of complex oligosaccharides;
• New chemical and/or chemo-enzymatic strategies for the synthesis and scalable production of non-natural libraries of glycans, or glycoconjugate analogues.

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).

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)
• umber and title of this funding opportunity

The letter of intent should be sent to:

Pamela A. Marino, Ph.D.
Telephone: 301-594-3827
Fax: 301-480-2802
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, 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.
• Applicants must budget funds in their final year for cross validation of their work products (e.g., shipping unique reagents, labor costs for reproducing methods).

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) 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, all applications must address how their proposed resource will make glycoscience more "integrated and accessible" by addressing these 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; and/or facilitates creation of off-the-shelf kits, affordable reagents, or new facile 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.

2) Project Milestones: All applications must provide milestones of project progress along with a timeline to completion.

3) Project cross-validation implementation plans: As part of the accessibility effort, all PDs/PIs of awarded projects must plan to cross validate their technology through another laboratory during the final budget year of the award. Applicants must provide an implementation plan that includes a general description of what will be needed for cross-validation activities. The plan should include:

• Timeframe within the final year of funding, provide an estimate of the amount of time that will be needed for cross-validation of the tools/methods/resources being developed.
• Plans must be described for how cross validation of the actual method/technology would be accomplished by another laboratory. It is expected that the cross-validating laboratory will be part of the Glycoscience Consortium (to be determined at the time of cross-validation) but in certain circumstances the necessary expertise may not be available among these other laboratories. In such cases the PD/PI can suggest another (external) laboratory that has the requisite expertise to cross validate their project.
• Plans for preparation of companion training materials for the proper use of the method/technology should be described.

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.

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.

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. 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. 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.

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.

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? 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? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves 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 in a synthetic route; make a carbohydrate library preparation easier; or develop ready-to-use assemblies that will easily interface with existing technologies?
• Easily available and affordable: Would the application, for example, open up new chemical space; improve synthetic yields thus making compounds produced less expensive; allow one to perform the process using standard lab equipment and reagents; or create off-the-shelf kits, reagents or assays?
• Easy to understand and adapt to different systems: Would the application, for example, provide training on proper use of the methods or technologies being developed; provide the user with relevant background information on use of the new methods and/or technologies within the broader context of glycobiology; and/or improve upon existing methods or technologies?

Cross-validation Implementation Plans

Does the PD/PI provide a plan that includes: 1) Timeframe within the final year of funding, providing an estimate of the amount of time that will be needed for cross-validation of the tools/methods/resources being developed, 2) Plans for how cross validation of the actual tool/method/resource would be accomplished by another laboratory, 3) Plans for preparation of companion training materials for the proper use of the tool/method/resource.

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 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.

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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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.

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.

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 NIH Program Officer 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.

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.

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: http://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 CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Pamela A. Marino, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3827
Email: [email protected]

William Greenberg
Center for Scientific Review (CSR)
Telephone: 301-435-1726
Email: [email protected]

Lisa Moeller, CRA
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3914
Email: [email protected]

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 .