National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
This Funding Opportunity Announcement (FOA) encourages applications from institutions/organizations proposing the development of targeted mass spectrometric assays (e.g., Multiple Reaction Monitoring) for proteins and peptides of primary interest to the obesity research community (e.g., Adiponectin, Leptin, Resistin, Neuropeptide Y, Alpha-melanocyte-stimulating hormone, Peptide YY, Glucagon-like peptide 1, Ghrelin, Adrenocorticotropin, Corticotropin-releasing hormone, Gastrin, Cholecystokinin, Secretin, Vasoactive intestinal peptide, gastric-inhibitory peptide, gastrin-releasing peptide, motilin, pancreatic polypeptide, RBP4, myostatin, FGF21). The proposed assays should be highly reproducible, easily transferable to other laboratories, easy to multiplex, and validated in human plasma or serum.
January 23, 2019
March 17, 2019
April 17, 2019 , by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates
No late applications will be accepted for this Funding Opportunity Announcement.
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.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
Many assays in basic and clinical science research rely exclusively on antibodies. However, there are no widely accepted guidelines or standardized methods to determine the validity of these reagents. Furthermore, many recent publications have highlighted the limitations of commercial antibodies, including failure to detect the intended target. The rigor and reproducibility of many assays commonly used by researchers in the obesity research field could be substantially improved by applying Mass Spectrometry (MS) instead of relying only on antibodies.
For several analytes and peptide/protein hormones, mass spectrometric assays that are more specific and less variable than previous measurements have been already developed, and some are already commonly used in high-throughput clinical chemistry laboratories. Despite the capability of several common mass spectrometers to analyze many analytes at once (e.g., by using Multiple Reaction Monitoring), most of these assays have not been multiplexed. There is an opportunity to combine simple and inexpensive separation methods such as solid-phase extraction (SPE) and µElution with Liquid Chromatography MS for developing multiplexed assays of interest to the obesity research community. The use of highly reproducible antibodies, such as the recombinant monoclonal antibodies, only for the enrichment of the proteins and peptides of interest in combination with MS assays for developing targeted Immuno-MRM assays, is also an option. However, when feasible it would be advantageous to develop multiplexed assays that require only simple fractionation/enrichment steps prior to the analysis by MS.
Purpose and Research Objectives
This FOA invites applications proposing the development of targeted mass spectrometric assays for proteins and peptides of primary interest to the obesity research community (e.g., Adiponectin, Leptin, Resistin, Neuropeptide Y, Alpha-melanocyte-stimulating hormone, Peptide YY, Glucagon-like peptide 1, Ghrelin, Adrenocorticotropin, Corticotropin-releasing hormone, Gastrin, Cholecystokinin, Secretin, Vasoactive intestinal peptide, gastric-inhibitory peptide, gastrin-releasing peptide, motilin, pancreatic polypeptide, RBP4, myostatin, FGF21). These assays should be validated quantifying the endogenous proteins and peptides of interest in human plasma or serum and should use isotopically labeled internal standards. These assays should be qualified demonstrating accurate quantification, precision, specificity, analytical sensitivity including Limit Of Detection (LOD), Upper Limit Of Quantification (ULOQ), and Lower Limit Of Quantification (LLOQ) (see also CPTAC guidelines). Ideally, these assays would have a small number of enrichment/fractionation steps prior to the MS analysis and would not use an antibody for enriching the analyte of interest. The goal should be to develop assays that are easily transferable to any laboratory that has appropriate expertise and access to a mass spectrometry facility. For this purpose, the use of easily accessible and inexpensive separation steps such as SPE and µElution is encouraged.
The development of a single multiplexed assay that includes all proteins and peptides of potential interest to the obesity research community would be optimal but might not be feasible due to the different chemical physical characteristics of several of the proteins/peptides of interest. Thus, the development of several multiplexed assays that target specific subsets of proteins/peptides should be considered. It should be noted that even the development of a highly reproducible and well qualified mass spectrometric assay for some specific analytes that requires special conditions is desirable.
Adiponectin, Leptin, Resistin, Neuropeptide Y, Alpha-melanocyte-stimulating hormone, Peptide YY, Glucagon-like peptide 1, Ghrelin, Adrenocorticotropin, Corticotropin-releasing hormone, Gastrin, Cholecystokinin, Secretin, Vasoactive intestinal peptide, gastric-inhibitory peptide, gastrin-releasing peptide, motilin, RBP4, myostatin, FGF21, and pancreatic polypeptide should be considered only as examples of potential proteins and peptides of interest to the obesity research community. The applicants should include in their application a list of proteins and peptides that are present in human plasma or serum and that are of potential interest to the obesity research community. The rationale used for compiling this list should be described. This could be achieved by, for example, assembling a group of experts in obesity research that express interest for well qualified assays of specific proteins and peptides.
The NIDDK will also work together with the awardees in facilitating the identification and prioritization of the proteins and peptides of interest in obesity research. For example, the NIDDK might publish a Request for Information (RFI) soliciting feedback from the scientific community for identifying proteins and peptides of primary interest to the obesity research community.
The NIDDK envisions that a successful application is likely to require an interdisciplinary team that includes expertise in clinical chemistry, obesity, and targeted mass spectrometry assay development.
Cooperative relationships and data sharing
The awardees are expected to work closely and collaboratively with the NIDDK in achieving the goals stated in the FOA.
A plan for data sharing and disseminating the successfully developed assays to the scientific community is required. This plan should include the deposition in a public portal, such as the CPTAC, of the assays characterization/validation data and of the Standard Operating Procedures (SOPs) to perform the assays.The NIDDK will appoint an NIDDK Project Scientist and an External Scientific Panel (ESP), consisting of two to three independent expert scientists. All Principal Investigators must participate in a bimonthly teleconference with the NIDDK assigned Project Scientist. The ESP and Project Scientist will participate in an annual site visit. Awardees are required to participate in this site visit as well, as to budget for the travel and participation of the ESP.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
The NIDDK intends to commit up to $1.5 million to fund 1 or 2 awards in FY 2019.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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:
John F. Connaughton, Ph.D.
Chief, Scientific Review Branch National Institute of Diabetes and Digestive and Kidney Diseases
All instructions in the SF424 (R&R) Application Guide must be followed.
Applicants should describe how the obesity research community could benefit from the availability of the developed assays.
An assays qualification plan consistent with recent CPTAC guidelines should be included. This plan should include demonstration of accurate quantification, precision, specificity, analytical sensitivity including Limit Of Detection (LOD), Upper Limit Of Quantification (ULOQ), and Lower Limit Of Quantification (LLOQ). This plan should also include the validation for quantifying the endogenous peptides and proteins of interest in human plasma or serum.
A plan for multiplexing the assays or developing multiplexed assays for subsets of the peptides/proteins of interest should be included.
A plan for compiling a list of proteins/peptides of potential interest to the obesity research community should be included.
Applicants should describe how the proposed assays will be made easily available to the scientific community.
The following modifications also apply:
It is the goal of NIDDK to further advance research by making resources, data, and reagents generated in whole or in part using funds from these U01 awards widely available to the research community with minimal restrictions.
A plan for data sharing and disseminating the successfully developed assays to the scientific community is required. This plan should include the deposition in a public portal, such as the CPTAC. All applications, regardless of the amount of direct costs requested for any one year, should address how they will share unique reagents, the assays characterization and validation data (including validation for accuracy, quantification, precision, specificity, analytical sensitivity, Limit Of Detection (LOD), Upper Limit Of Quantification (ULOQ), and Lower Limit Of Quantification (LLOQ)), and Standard Operating Procedures (SOPs) necessary for replicating the assays.
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.
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.
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.
Only the review criteria described below will be considered in the review process. Applications submitted in support of the NIH mission 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 the prior research that serves as the key support for the proposed project rigorous? 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?
Specific to this FOA : Has the applicant described how the obesity research community could benefit from the availability of the developed assays?
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 included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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?
Specific to this FOA:
Are the proposed assays going to be easily transferable to any laboratory that has a reasonable skill set and access to a mass spectrometry facility?
Is the data and key reagents sharing plan appropriate for achieving the program’s goal of developing assays that can be easily replicated by the scientific community?
Is the proposed assays qualification plan consistent with achieving the goals of the program? For example, does the plan include a demonstration of accurate quantification, precision, specificity, and analytical sensitivity including Limit Of Detection (LOD), Upper Limit Of Quantification (ULOQ), and Lower Limit Of Quantification (LLOQ)? Does the proposed project include a plan for validating the assays quantifying the endogenous peptides/proteins of interest in human plasma/serum? Is there a plan for multiplexing the assays? Is there a plan for compiling a list of proteins/peptides of interest to the obesity research community?
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 individuals of all ages (including children and older adults), 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?
For research that involves human subjects but does not involve one of the 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 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.
Individuals Across the Lifespan
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 individuals of all ages (including children and older adults) 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.
Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group convened by the NIDDK 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.
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 OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 75 , and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement U01, 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 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:
• Awardee(s) will be primarily responsible for defining the objectives and approaches, planning, conduct, analysis, and publication of results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award.
• The Principal Investigator/Program Director will assume responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the research supported under this Funding Opportunity Announcement in accordance with the terms and conditions of award, as well as all pertinent laws, regulations, and policies.
• The Awardee will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current HHS, PHS, and NIH policies.
• All staff of the Awardee will maintain the confidentiality of the information developed by the investigations, including, without limitation, study protocols, data analysis, conclusions, as well as any confidential information received by third party collaborators.
• Awardees must analyze, publish and/or publicly release and disseminate results, data, and other products of the study in a timely manner, concordant with the approved plan for making quality-assured data and materials available to the scientific community and the NIH, consistent with NIH policies and goals of the FOA.
• All staff of the Awardee will be required to participate in a cooperative and interactive manner with NIH staff.
• Awardees are expected to share data, materials, methods, and SOPs of the developed mass spectrometric assays with the scientific community.
• Awardees will submit a list of milestones and project deliverables to the NIDDK.
• Awardees agree that third party collaborations (including both industry and academia) should be governed by a research collaboration agreement (e.g. CTA, RCA, etc.) with terms that ensure that the developed assays, the validation data, and SOPs will be made available to the scientific community through a public portal in accordance with the Cooperative Agreement and all applicable NIH policies and procedures. The NIDDK Program staff will consult with others at NIH including the Technology Advancement Office.
• Awardees agree that all hybridomas and recombinant antibodies clones developed within this cooperative agreement or used in the assays will be made available through the Developmental Studies Hybridoma Bank (http://dshb.biology.uiowa.edu/).
• Awardees must operate in accordance with processes and goals as delineated in the Funding Opportunity Announcement.
• Upon completion or termination of the research project(s), the awardees are responsible for making all developed assays, the validation data, and SOPs broadly available and making them accessible to the research community according to the NIH-approved data sharing and dissemination plan. This should be accomplished on timely manner and no later than the end of the study.
• The awardee will be responsible for accepting and implementing the goals, priorities, procedures, protocols, and policies agreed with the ESP and the NIDDK.
• Awardees agree to organize a yearly site visit based on the availability of the ESP members and of the NIDDK Project Scientist, and to reimburse the ESP members for the travel expenses for attending this site visit following the NIH travel guidelines.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
• The NIDDK will designate program staff, including a Program Officer and a Grants Management Specialist, to provide stewardship and administrative oversight of the cooperative agreement. The Program Officer and Grants Management Specialist will be named in the Notice of Grant Award.
• The NIH will invite experts with relevant scientific expertise to provide feedback to the NIH. The External Experts will meet to review the progress of the research projects and to advise NIH staff of scientific developments and opportunities that may enhance the achievement of the study goals.
• An NIDDK Project Scientist will be substantially involved in this project above and beyond the normal stewardship of an NIDDK Program Official as follows:
• The NIDDK reserves the right to terminate or curtail any study or any individual award in the event of (1) substantial shortfall in data collection or submission, quality control, or other major breach, (2) substantive changes in a study protocol that are not in keeping with the objectives of the FOA, or (3) concerns related to human subject safety that prompt the need for premature termination.
• The NIH may enlist additional scientific consultants as necessary from within the NIH whose function will be to assist the Project Scientist in carrying out the goals and aims of the approved studies.
• The NIH Project Scientist will have substantial scientific programmatic involvement in research coordination and performance monitoring. The dominant role and primary responsibility for these activities resides with the awardee; however, specific tasks and activities in carrying out the studies will be shared among the awardees and the NIH Project Scientist.
• The NIH Project Scientist serves as a resource with respect to facilitate interaction with other ongoing NIH activities.
• The NIH Project Scientist or designee may coordinate activities among awardees by assisting in the design, development, and coordination of a common research protocol and statistical evaluations of data and in the publication of results.
• The NIH Project Scientist may review procedures for assessing data quality and monitor study performance.
• The NIH Project Scientist may be a co-author on study publications. In general, to warrant co-authorship, the NIH staff must have contributed to one or more of the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participation in analysis and interpretation of study results; and (d) preparation and authorship of pertinent manuscripts.
Areas of Joint Responsibility include:
After the award an initial face-to-face meeting between the Project Scientist, other relevant NIH staff, and the awardees will be scheduled. This meeting will have the main purpose of jumpstarting the project and evaluating and modifying as necessary the proposed milestones.
Expert Scientific Panel (ESP)
A panel of two to three independent scientific experts (ESP) will be appointed by the NIDDK and meet with the NIDDK Project Scientist, Program Director, and the Principal Investigator(s) at least once a year. The ESP will be updated on progress and give feedback to the NIH on adjustments that might be needed in the research projects.
Disagreements that may arise in scientific/technical matter or programmatic matters (within the scope of the award) between award recipients and the NIDDK may be brought to arbitration. The arbitration panel will be composed of the Principal Investigator, one NIH designee, and a third designee from the independent panel of review experts. This special dispute resolution procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 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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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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