Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
National Library of Medicine (NLM)
U24 Resource-Related Research Projects – Cooperative Agreements
New
RFA-LM-20-001 - Regional Medical Libraries for the Network of the National Library of Medicine (UG4) (Clinical Trial Not Allowed)
93.879
This Funding Opportunity Announcement (FOA) invites cooperative agreement (U24) applications for organizations to serve as the Evaluation Center for the Network of the National Library of Medicine (NNLM). The goal of the NNLM is to advance the progress of medicine, improve public health by providing U.S. health professionals and the public with equal access to biomedical data and information, and improve individuals' access to information to enable them to make informed decisions about their health. The NNLM works through libraries and other member organizations to support a workforce for biomedical and health information resources and data, improve health literacy, and increase health equity. Seven health sciences libraries function as the Regional Medical Library (RML) for their respective region. The RMLs work together to coordinate a network of member libraries and other organizations to carry out local, regional and national programs. These Network members develop collaborations with other organizations to improve access to biomedical information resources throughout the nation. The NNLM program is coordinated by the NLM Office of Engagement and Training. The NNLM Evaluation Center (NEC) will coordinate the assessment of the impact, efficacy and value of NNLM activities, services, and resources. A special focus will be placed on assessing community engagement and measuring its impact on persons who experience health disparities, and populations underrepresented in biomedical research. The NEC’s activities will include, among others, developing evaluation tools, planning studies, providing evaluation training to the RMLs, Offices, Centers, and sub-awardees of the NNLM, and assessing the effectiveness of national initiatives and selected programs. The NEC will provide NNLM with essential information for developing, maintaining, and evolving effective health information engagement and outreach activities for diverse populations.
August 28, 2020
September 28, 2020
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
Not Applicable
December 2020
January 2021
May 2021
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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.
Background
The National Library of Medicine (NLM) is the world’s largest biomedical library and one of twenty-seven institutes and centers that form the National Institutes of Health (NIH). Each day, more than four million people use NLM resources such as PubMed, ClinicalTrials.gov, and MedlinePlus. In addition to disseminating the world’s biomedical research and providing trusted health information, NLM has a strong commitment to engaging with its diverse audiences. One of NLM’s innovative approaches to meeting the needs of its scholarly, clinical, and community stakeholders is the Network of the National Library of Medicine (NNLM).
NNLM has a long, distinguished history. The Medical Library Assistance Act of 1965 (MLAA, P.L. 89-291) established the NNLM to assist the development of medical libraries’ services and to facilitate the dissemination and use of information related to health sciences. Over time, a growing emphasis has been placed on increasing the impact of the NNLM through partnerships with NLM and member organizations, including health sciences, hospital, academic and public libraries, as well as health professionals, data organizations, and community-based organizations. The NLM Office of Engagement and Training partners with the NNLM to coordinate and serve as a liaison with NLM and other NIH Institutes.
The NNLM consists of seven Regional Medical Libraries (RMLs) and approximately 8,000 member organizations located throughout the US. The NNLM is supported by three Offices – Web Services, Training and Public Health Coordination and several specialized Centers. Within their focus areas, the NNLM Offices and Centers serve critical roles, including: coordinators of national programs; communication; consensus-builders for NNLM-wide standards; and monitors of contents and outputs for quality and accuracy. The NNLM Steering Committee (SC) provides overall integration among NNLM RMLs, Offices, Centers, and network partners. The SC implements common policies and operational practices for the NNLM, ensuring that the NNLM components work in concert to develop and continually improve regional and national outreach, engagement and training programs. See the NNLM website and the NNLM Workbook for more information about the structure and functions of the NNLM.
The NNLM is a key partner in helping NLM achieve the vision outlined in the NLM Strategic Plan 2017-2027 “to reach more people in more ways through enhanced dissemination and engagement pathways.” The NNLM program supports NLM’s goal to enhance its research, development, training, and information services to make more biomedical data findable, accessible, interoperable, and reusable (FAIR), to invent the tools and services to turn data and information into knowledge and insight, and to develop the workforce for this work. To implement this vision, NNLM will require new partnerships and ways to engage with stakeholders in the public and private sectors, including researchers, librarians, health professionals, entrepreneurs and innovators, and the public, especially persons who experience health disparities and underrepresented populations.
The NNLM brings quality health and biomedical information resources within easy reach of the public and health professionals, especially in underserved communities. The goal of these efforts, which target librarians, researchers, clinicians, health professionals and members of the public, is to increase health equity through information. NLM’s many databases, tools, and services, including PubMed, MedlinePlus, ClinicalTrials.gov, HealthReach, Genetics Home Reference, database of Genotypes and Phenotypes, Unified Medical Language System – provide trusted information and data about health, genetics, drugs, chemicals, and many other topics. Effective community engagement by NNLM is critical to assuring the NLM resources reach a wide range of audiences — from librarians to researchers and clinicians, from teenagers to their parents and seniors, and from policymakers to the public. Community engagement for information access encompasses promoting awareness of available information resources, developing an understanding of users’ information needs, facilitating access, and ensuring the ability to use information resources.
Program evaluation has always been an important focus at NNLM. Over the years, the NNLM National Evaluation Office (NEO) has developed evaluation guides and resources for planning and evaluating outcomes-based health information outreach. NEO also supported the Network with training and programming. Over the decades, the efforts grew to encompass evaluation and data management technologies and to development of centralized approaches to evaluating large-scale, multi-site national initiatives. Some of the evaluation technologies that have proved effective include, the REDCap survey, data collection and analysis tool, and Tableau data visualization tools. Recent efforts have also focused on standardization of evaluation plans for NNLM, and improvement of data capture and reporting approaches. For additional information about evaluation approaches that the NNLM is currently using see the NNLM Workbook.
Purpose
This Funding Opportunity Announcement (FOA) invites cooperative agreement (U24) applications for the Network of the National Library of Medicine (NNLM) Evaluation Center. The NEC will develop and operate an expanded evaluation program for NNLM building upon previous accomplishments when possible. The NEC will assess the impact, efficacy and value of NNLM activities, services, and resources. A special focus will be placed on assessing community engagement, particularly its impact on persons who experience health disparities and underrepresented populations. Quality evaluation will contribute to the NNLM establishing evidence-based engagement and outreach practices that can be deployed on a national scale and tailored to meet the needs of specific audiences. The NEC’s activities will include, among others, developing evaluation tools, planning studies, providing evaluation training to NNLM RMLs, Offices, Centers and sub-awardees, and assessing effectiveness of national initiatives and selected programs. Ultimately, the Center will provide NNLM with essential information for developing, maintaining, and evolving effective health information engagement and outreach activities for diverse populations.
See Section VIII. Other Information for award authorities and regulations.
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. Only those application types listed here are allowed for this FOA.
Need help determining whether you are doing a clinical trial?
NLM intends to commit $800,000 in FY 2021 to fund 1 award.
Applicants may request up to $610,000 in direct costs per year. Application budgets need to reflect the actual needs of the proposed project.
The proposed project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
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
For-Profit Organizations
Local Governments
Federal Governments
Other
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 not 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.
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:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace 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.
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:
Zoe Huang, MD
National Library of Medicine (NLM)
Telephone: 301-594-4937
Email: huangz@mail.nih.gov
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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:
Describe the organizational and governance structure and provide an organizational chart for the NEC.
The NEC should address the engagement and outreach evaluation and analysis needs of the NNLM. The application should demonstrate a broad understanding of the overarching goals of the Network of the National Library of Medicine and the importance of a standardized coordinated evaluation approach. It should also propose novel or cutting-edge evaluation techniques and technology-based solutions to evaluation planning, as well as data collection from multiple sites, data management, and analysis. Data analytic approach should include a combination of theory and evidence-based qualitative and quantitative methods. The application should include a clear plan for statistical analysis of the integrated quantitative data from multiple sites. Potential problems, alternative strategies, and benchmarks for success should be presented. Finally, the application should include clear, actionable milestones and timelines proposed to establish the NEC, meet program goals, and assess performance and progress for a five-year time frame.
Describe plans for the Network of the National Library of Medicine (NNLM) Evaluation Center to:
The NEC’s PD/PI will serve on the NNLM Steering Committee, provide regular feedback to the SC, and provide SC annual budget and activity reports to the NLM OET.
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.
The following modifications also apply:
When involving human subjects research, clinical research, and/or NIH-definedclinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
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.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is 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?
Does the proposed NEC address the engagement and outreach evaluation and analysis needs of the NNLM?
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 proposed staff have experience developing evaluation guidance resources and training materials, as well as conducting evaluation training? Does the proposed staff have experience with programs that focus on diverse participant populations and communities affected by health disparities, including those underrepresented in biomedical research?
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?
Does the application propose novel or cutting-edge evaluation techniques and technology-based solutions to evaluation planning, data collection, management, and analysis?
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?
Is there an effective plan for prioritizing tasks and managing multiple activities in a way that furthers NNLM mission? Does the evaluation process allow enough flexibility to accommodate various evaluation strategies to be employed by RMLs/Offices/Centers? Do data analytic approaches include a combination of theory-based qualitative methods and quantitative methods? Does the plan include adequate strategies for analyzing and integrating data from multiple sites?
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?
Will the project have the data collection, management, analysis, and visualization tools needed to support the overall mission of the NEC?
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.
Milestones and Timeline
Are clear, actionable milestones and timelines proposed to establish the NEC, to meet program goals, and to assess performance and progress for a five-year time frame?
For research that involves human subjects but does not involve one of thecategories 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.
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.
Not Applicable
Not Applicable
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Library of Medicine, 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 will receive a written critique.
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.
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 NLM Board of Regents. The following will be considered in making funding decisions:
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.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
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. 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.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
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.
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 reside 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) primary responsibilities
The PD/PI will agree to accept the close coordination, cooperation, and participation of the NLM staff (Project Scientists (PS), Project Coordinator (PC), Program Official (PO) and other appropriate NLM staff) in those aspects of program and technical management of the project as described below. Specifically, the PD/PI supported by the Cooperative Agreement will:
NIH program staff provides scientific technical assistance and advice to recipients of cooperative agreements during the conduct of an activity, above and beyond the levels required normally for program stewardship of grants, but without dominating the relationship, as described below.
Project Scientist (PS) Responsibilities
One or more designated NLM staff members, acting as Project Scientist (PS), will have substantial programmatic involvement. The role of the PS will be to facilitate and not to direct. This includes facilitating the partnership and collaboration between NNLM NEC, RMLs, Offices and Centers, national partners, and NLM. The PS role includes helping to maintain the overall balance in the program commensurate with the functions and scope of the program’s activities, facilitating communication and coordination, and ensuring that the activities of the awardees are consistent with the mission of the NNLM. Specifically, the NLM Project Scientist(s):
Project Coordinator (PC) Responsibilities
The Project Coordinator will work in partnership with awardees, PSs and the PO to help coordinate activities and resources across the NNLM NEC program to ensure effective and efficient performance of the aims and mission of the NNLM NEC. Specifically, the NLM PC:
Program Official (PO) Responsibilities
The PO is the NIH official responsible for the programmatic, scientific, and/or technical aspects of the award that provides normal program stewardship of the award. The PO will have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. The PO may use information obtained from the data for the preparation of internal and external reports on the activities of the project. The PO will work in partnership with the PC and PSs in regards to providing technical assistance to the NNLM NEC. Normal PO stewardship includes:
Enforcement of general statutory, regulatory, or policy requirements;
Areas of Joint Responsibility include:
The PD/PIs of the NNLM RMLs, Offices and Centers, and the PSs and PC will be jointly responsible for the coordination and collaboration of NNLM NEC activities and the integration of individual projects with other appropriate NLM programs. Joint responsibilities include:
Steering Committee(SC)
The Steering Committee (SC) will provide overall integration among NNLM RMLs, Offices and Centers (including NNLM NEC), and network partners. It will also serve as an interface between the individual projects funded under this FOA and appropriate NLM programs. The SC will consist of the PD/PI for each NNLM RML, heads of the Offices and Centers (including NNLM NEC), and the PC. The PSs and the PO will be nonvoting members. When appropriate, the SC may include representatives from outside working groups and NLM staff who will be nonvoting members. The SC Chair will be elected from among the NNLM voting members, but may not be an NLM or NIH staff member. Additional information about the NNSC and current procedures is available in the NNLM Organizational Workbook.
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: 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.
A final RPPR, 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 agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings.Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threatensubmission by the due date, and 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)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email:GrantsInfo@nih.gov(preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support(Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email:support@grants.gov
Alan VanBiervliet, MA PhD
National Library of Medicine (NLM)
Telephone: 301- 594-4882
Email: alan.vanbiervliet@mail.nih.gov
Zoe Huang, MD
National Library of Medicine (NLM)
Telephone: 301-594-4937
Email:huangz@mail.nih.gov
Samantha Tempchin
National Library of Medicine (NLM)
Telephone: 301-496-4221
Email: tempchins@mail.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.