This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (https://commonfund.nih.gov/) through the NIH Office of the NIH Director, Office of Strategic Coordination (https://commonfund.nih.gov/). All NIH Institutes and Centers participate in Common Fund initiatives. The FOA will be administered by the National Cancer Institute (NCI) on behalf of the NIH.
The Common Fund Program - Accelerating Translation of Glycoscience: Integration and Accessibility - aims to develop 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.This FOA solicits development of new, more easily accessible tools, reagents, and technologies to facilitate identification, tracking, manipulation, and analysis of glycans with their biological binding partners and determine their functions. This initiative may build on efforts that interface with existing technologies and procedures to make them easier to access and use. As applicable, efforts must consider: factors for scale-up; efforts to make instrumentation broadly accessible and cost-effective for the end-user; and compatibility of data generated with integration into existing databases. While this FOA seeks development of new or more robust tools and technologies, the related RFA RM-18-037 is a solicitation for adaptation of existing technologies for simplification and ease of accessibility to the greater biomedical research community.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
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.
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.
This FOA solicits development of new, more easily accessible tools, reagents, and technologies to facilitate identification, tracking, manipulation, and analysis of glycans with their biological binding partners and determine their functions. This initiative may build on efforts that interface with existing technologies and procedures to make them easier to access and use. As applicable, efforts must consider: factors for scale-up; efforts to make instrumentation broadly accessible and cost-effective for the end-user; and compatibility of data generated with integration into existing databases. While this FOA seeks development of new or more robust tools and technologies, the related FOA RFA-RM-18-037 solicits applications for adaptation of existing technologies for application to the glycosciences in a manner that is straight forward and accessible for non-specialists.
The term glycan herein applies to any biologically occurring form (N- or O-linked glycans, glycolipids, glycosaminoglycans, microbial polysaccharides) each having its own chemical repertoire of presentation or modifications.
This program has been running for four years but certain research tools remain weakly represented where preferential consideration may be given. Areas of current needs include:
In addition to the list above, this program continues to have an interest in a broad variety of tools represented by, but not limited to, those in the list below.
Glycoscience research affects the missions of all NIH Institutes and Centers (ICs). Several ICs have described areas of glycoscience that are particularly encouraged through this FOA. However, applications relevant to the missions of other ICs also are welcome.
The National Institute of Diabetes and Digestive and Kidney Diseases for example encourages the development of technologies and tools for:
The National Institute of Child Health and Human Development encourages the development of reagents to assay antimicrobial activities of pure human milk oligosaccharides individually or in combination to investigate potential synergy.
The National Institute of Drug Abuse encourages the development of tools to study how glycans contribute to the regulation of addictive behaviors or immune regulation, such as investigating the roles of glycans in modulating neurotransmitter receptors, neuronal substrates, transporters, ion channels, and cell adhesion molecules.
The National Eye Institute encourages development of technologies and tools that help in facile analysis of retinal, corneal and lenticular glycoproteins and glycolipids. Analytical methods to better understand the role of mucins and carbohydrate-binding proteins in the homeostasis of the ocular surface – are especially encouraged. Similarly, tools to further dissect the biology of galectins in ocular angiogenesis and corneal neovascularization are desired.
The National Heart, Lung, and Blood Institute encourages development of the following tools:
The National Institute of Allergy and Infectious Disease encourages the development of:
The National Institute of Arthritis and Musculoskeletal and Skin Diseases encourages the development of technologies and tools that:
The National Institute of Dental and Craniofacial Research encourages development of technologies and tools for in situ interrogation of glycan expression in oral pathogen and host interactions with relevance to oral infection and inflammation and to oral opportunistic infections, including those associated with HIV/AIDS.The National Cancer Institute encourages the development of technologies and tools that interrogate alterations in glycan expression of cancers contributing to tumor progression and metastasis. To this end there is a great need for high throughput technologies to analyze small amounts of clinical material to provide breadth and depth coverage of glycan profile characterization in terms of the variety of glycan species covering several orders of magnitude in abundance and their detailed structural characterization.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
The NIH intends to commit $2,000,000 in FY 2019, contingent upon receiving scientifically meritorious applications s. Approximately 5 awards are anticipated from this solicitation.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
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.
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.
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.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
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.
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:
The letter of intent should be sent to:
Karl E. Krueger, Ph.D.
All instructions in the SF424 (R&R) Application Guide must be followed.
The following additional budget-related information must be included:
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:
2) Project Milestones: All applications must provide milestones of project progress along with a timeline to completion. Include a description of plans to make this tool/technology available to the greater scientific community.
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:
4) The application should describe how the tool/technology being addressed represents a significant road-block for non-specialists in approaching a glycoscience-related research problem and how the adaptation proposed simplifies its application to where most research labs can carry it through.
5) The proposed research should involve innovative approaches to significantly reduce the complexity or specialized expertise needed to apply the stated technology/tool.
The following modifications also apply:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
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.
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.
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.
Applications Involving the NIH Intramural Research Program
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 Common Fund through 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.
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.
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 those 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?
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:
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 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.
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.
Information regarding the disposition of applications is available 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.
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.
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) will have the primary responsibility for:
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:
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:
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.
Areas of Joint Responsibility include:
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:
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:
The PD/PI(s) and NIH Project Scientist(s) will initiate the formation of the Coordinating Group and will facilitate its activities.
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
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.
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