It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Purpose

This Funding Opportunity Announcement (FOA) invites cooperative agreement (UG4) applications for Regional Medical Libraries (RMLs) as the integral component of the Network of the National Library of Medicine (NNLM or Network). 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 mission of the NNLM is to provide U.S. researchers, health professionals, public health workforce, educators, and the public with equal access to biomedical and health information resources and data. Seven health sciences libraries will function as the RML for their respective region to accomplish these goals. NNLM’s main goals are to work through libraries and other members to support a highly trained workforce for biomedical and health information resources and data, improve health literacy, and increase health equity through information. Through meaningful engagement strategies the NNLM increases health information access and use for all audiences, including underrepresented populations. The NNLM program also 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.

RMLs are regional hubs of the NNLM that provide training, funding, and engagement opportunities for member libraries and other organizations to carry out regional and national programs. Regionally, RMLs assess and interpret the needs of current and potential audiences to expand the reach and impact of the NLM. Nationally, the RMLs will ensure continuity of quality service for core programs of the NNLM, and cooperatively design, implement, and evaluate innovative approaches to serving the biomedical and health information needs of researchers, health professionals, public health workforce, educators, and the public. RMLs and NNLM members act as trusted ambassadors between NLM and the communities they serve. RMLs working with and through partner/resource libraries, members, and other organizations with shared visions to carry out regional and national programs contributing to sustainability of partnerships and program activities. The overall NNLM program is coordinated by the NLM’s Office of Engagement and Training (OET).

Background

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. Partnerships enable RMLs opportunities to engage with stakeholders in the public and private sectors, including researchers, librarians, health professionals, entrepreneurs and innovators, underrepresented populations, and the public.

Through its products and services, NLM supports librarians, researchers, health professionals, public health workforce, educators, and the public who seek current and trusted biomedical information and data. 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, cover health, genetics, drugs, chemicals, and many other topics. Effective community engagement by the RMLs is critical to assuring the NLM resources and data reach its wide range of audiences from librarians to researchers and clinicians, from teenagers to their parents and seniors, 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. It also should support and promote the skills and abilities to understand and use information; the technology and physical means, such as demonstrations, that facilitate information access; and the creation and testing of informational materials and content.

NLM recognizes the ever-changing landscape for health sciences libraries, due in part to the evolving information needs of students, faculty, researchers, and practitioners, changes in the publishing industry, and changes in digital technologies. Libraries are also impacted by the ways people seek and use health information, as well as programs supporting lifelong learning by the general public. NNLM is a key NLM partner for discovering and enabling a new generation of data-ready librarians and informationists that position libraries as hubs for data access and data-driven research support. A primary role for NNLM is to support skills acquisition for data research management and data literacy. These skills can help library staff meet the data needs of researchers, health professionals, public health workforce, educators, and the public, as well as facilitate interdisciplinary engagement with entrepreneurs and innovators from other academic fields and professions.

Program Structure of the Regional Medical Libraries (RMLs)

Each RML must consist of two core components: the Administrative Core and RML Program Core. The RMLs will work cooperatively with one another, the NNLM Offices and Centers, and the OET to maintain continuity of the quality programs of the NNLM and develop new programs to serve evolving health information needs.

In addition to the RMLs outlined above, this FOA also solicits proposals to host one or more of the three NNLM Offices, which are functional units located in RMLs that serve the entire the NNLM program. These offices are the NNLM Web Services Office (NWSO), the NNLM Training Office (NTO), and the NNLM Public Health Coordination Office (NPHCO). Application for a NNLM Office is optional and includes an additional core component. Within their focus areas, the NNLM Offices and Centers serve critical roles, including: coordinators of national programs; consensus-builders for NNLM-wide standards; and monitors of contents and outputs for quality and accuracy. The NNLM Offices can share some resources with the host RML. However, the administration, staff, and budget of the proposed NNLM Office should be focused on national activities and initiatives. The Project Leads for the Offices should be different from the Program Director/Principal Investigator (PD/PI) of the RML. A RML applicant can use a subaward mechanism in their application to fulfill the role of a NNLM Office. Only one of each type of NNLM Office will be selected for funding. However, an RML can apply for and be selected to host more than one NNLM Office.

Each RML must plan to participate in the NNLM Steering Committee (SC) which provides overall integration among NNLM RMLs, Offices, Centers, and network partners. Participation in the SC contributes substantially to the development of the vision, mission, strategies, standards, oversight, and activities of the NNLM. The SC 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, and the NLM Project Coordinator. The SC will implement common operational and evaluation processes for the NNLM, ensuring that the NNLM components work in concert to develop and continually improve regional and national outreach, engagement and education programs. The SC will monitor program performance to identify successful strategies for expansion and replication, and to recommend corrective action when needed. Additional information about the SC and current procedures is available in the NNLM Workbook.

Technical Assistance Webinar and Support Materials

• Wednesday July 8, 2020 from 3:00-4:00pm ET
• Webinar URL - https://nih.webex.com/nih/onstage/g.php?MTID=e7f4d5d6ca735a87c7ac18b19efd94df0
• Event Number - 625 155 530
• Event Password - nlmug4
• Audio Conference: To receive a call back, provide your phone number when you join the event, or call the number below and enter the access code. Call-in toll number (US/Canada) 1-650-479-3208 Access code: 625 155 530
• Submit Questions in advance or during the meeting - NLMEPLM@mail.nlm.nih.gov
• Handout for meeting and FAQs - http://www.nlm.nih.gov/ep/UG4Webinar.html

NLM will conduct a technical assistance webinar regarding RFA-LM-20-001 "Regional Medical Libraries for the Network of the National Library of Medicine (UG4)." You can access the webinar via the URL listed above from a computer or mobile device. You can also listen in to the webinar via phone using the dial in number and passcode listed above. The meeting will review the purpose and objectives of the FOA, review application instructions, and address questions from the community concerning the FOA. All prospective applicants are invited to participate. Following the meeting questions and answers will be posted at http://www.nlm.nih.gov/ep/RML.html .

Additional information about the NNLM and the existing RMLs can be found at the NNLM website (https://nnlm.gov). Current operational procedures, evaluation methods, and reporting plans of the NNLM and the RMLs are found in the NNLM Organizational Workbook (https://nnlm.gov/workbook).

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

It is expected that the PD/PI will be an established health sciences library director or a senior library administrator who reports directly to an official with broad trans-institutional authority, and who has the authority and influence necessary to successfully develop, manage and evaluate the performance of a RML supporting the activities described below. The PD/PI is also expected to have the authority to partner with internal and external stakeholders to support the RML activities and fully integrate the RML into the NNLM. The NIH Multi PD/PI option https://grants.nih.gov/grants/multi_pi/ can also be used for the Program leadership. The multi-PD/PI option presents an important opportunity for investigators seeking support for projects or activities that benefits from a team science approach.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number is allowed.

This FOA is intended for U.S. health sciences libraries that will function as RMLs within their geographical region. One award will be made in each of the following seven Regional areas:

Region 1: Delaware, Kentucky, Maryland, New Jersey, North Carolina, Pennsylvania, Virginia, West Virginia, and the District of Columbia.

Region 2: Alabama, Florida, Georgia, Mississippi, South Carolina, Tennessee, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands.

Region 3: Arkansas, Kansas, Louisiana, Missouri, Nebraska, Oklahoma, and Texas.

Region 4: Arizona, Idaho, Colorado, Montana, New Mexico, North Dakota, South Dakota, Utah, and Wyoming.

Region 5: Alaska, California, Hawaii, Nevada, Oregon, Washington, and U.S. Territories and Freely Associated States in the Pacific.

Region 6: Illinois, Indiana, Iowa, Michigan, Minnesota, Ohio, and Wisconsin.

Region 7: Connecticut, Massachusetts, Maine, New Hampshire, New York, Rhode Island, and Vermont.

Awards for the optional NNLM Offices (NWSO, NTO, and NPHCO) will only be made to applications that have been selected for a RML award.

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Zoe Huang, MD
Telephone: 301-594-4937
Email: huangz@mail.nih.gov

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	6
Admin Core	6
RML Core	12
NNLM Office (use for NNLM Web Services Office, NNLM Training Office, and NNLM Public Health Coordination Office)	6

Additional page limits 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 a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: Required
• RML Core: Required
• NNLM Web Services Office (NWSO): optional
• NNLM Training Office (NTO): optional
• NNLM Public Health Coordination Office (NPHCO): optional

When preparing your application, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Specific Aims: Concisely state the overall aims of the proposed RML, including how successful coordination and cooperation among organizations within the region and nationally will be obtained.

Research Strategy:

Provide an overall description of the structure, organization, and functions of the proposed RML. Summarize plans for effectively carrying out the proposed core functions. Applicants must present an integrated plan that will be responsive to the evolving health information needs of the region, the United States and the NNLM. The focus should be that all groups within your region require equal access to the highest level of health information regardless of an individual or communities demographics. The emphasis of the overall program should be to bring quality health, public health, and biomedical information resources within easy reach of the public and all health and public health professionals, with emphasis on underrepresented populations. The RML should improve and expand current services and coordination among the NNLM to identify and build on regional areas of expertise. In partnership, NLM, the RMLs and the NNLM should be able to deliver a flexible, rapid response to changing regional and national needs, user expectations, geographic factors, and environmental conditions. NNLM members should act as a "field force or trusted ambassadors for NLM products and services, providing information services, engagement, and instruction, or funding for projects to do the same, to the public, researchers, health professionals, and public health workforce directly and through NNLM member organizations. Each RML is expected to:

• Develop approaches to promote awareness of, improve access to, and enable use of NLM’s authoritative resources and data;
• Develop and support a diverse workforce to access biomedical and health information resources and data, and to support data-driven research;
• Engage authentically with current and future audiences to increase information access, with priority focus on underrepresented populations;
• Provide community-driven innovative approaches and interventions for biomedical and health information access and use;
• Contribute substantially to the development of vision, strategies, standards, oversight, and activities for NNLM’s national program in collaboration with other RMLs, NNLM Offices and Centers, and NLM;
• Assess and interpret the biomedical and health information needs of NNLM members within the region and provide solutions within scope of the NNLM program;
• Partner and collaborate with Network members and other organizations to accomplish national and regional program goals; and
• Conduct formative and summative evaluation of the effectiveness, impact, and value of RML program.

Describe any unique experiences or resources the applicant institution has developed solely or in partnership with other health information organizations, including community-based organizations, Minority-Serving Institutions (MSIs), Historically Black Colleges and Universities (HCBU), Tribal institutions, and Hispanic Association of Colleges and Universities (HACU) institutions. Focus particularly on experiences and resources that will be valuable for achieving the goals of the proposed RML and NNLM.

Describe the proposed relationship of the applicant institution and any participating partner institutions (e.g., resource libraries or partner libraries), if applicable. Describe the integration of the partners within the RML: what each partner will contribute; how each partner will have input and participate in decision-making; and how the partners will maintain ongoing communication. It is critical that: the inclusion of partners should be well justified; partners each contribute essential elements or unique strengths to the overall program; and there is a strong plan on how the partners work together. Discuss plans for managing competing institutional perspectives, disparities in institutional culture and resources, and sharing of institutional expertise and resources. Plans for collaborative leadership and communication should consider the inclusion of diverse partners and stakeholders such as Minority-Serving Institutions (MSIs), HBCUs, Tribal institutions, HACU institutions, and community-based organizations

The NLM is committed to inclusion, transparency, and accountability in the administrative management and programs of RMLs. Applicants should describe: how they plan to collect data and analyze metrics and how leadership will monitor progress. Meaningful measures of success pertain to impact and quality, as well as systematic quantitative tracking and reporting. Describe plans to use the tools and guidelines developed by the NNLM Evaluation Center to target and measure success. This section should not make reference to any NNLM Office for which the applicant is currently applying.

Letters of Support: Letters of Support should state the institutional support for being part of NNLM. State how the applicant institution and any partner institutions anticipate participating in NNLM programs using subcontracts.

The application is expected to include letters from the officials responsible for intellectual property issues at the applicant institutions (including sub-contractor institutions) stating that the institution supports and agrees to abide by the conditions set forth in the application. These letters should be clear expressions of commitment consistent with achieving the goals of the program.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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.

When preparing your application, use Component Type Admin Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• Without duplicating information contained in the biosketches, explain the expertise of the individual(s) proposed to manage the RML staff and administer day-to-day operations, especially as it relates to: experience in large health sciences libraries; understanding of basic public health and health care policies and national health objectives; experience with grants; experience in preparation and management of budgets; writing skills; and experience in interpersonal and inter-organizational relations.

Budget forms appropriate for the specific component will be included in the application package. The direct costs per year for the Administrative Core and the RML Program Core combined should be no more than $975,000. The budget will depend on regional needs, and the proposed regional and national activities.

The expectation is that administrative operations and costs detailed in this section are streamlined to make the majority of RML funds available for supporting access to biomedical health information, outreach and educational activities.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Describe the specific aims to address: the organization, governance, collaboration, communication, monitoring for continuous improvement, evaluation and reporting for the RML; how the RML will collaboratively build an inclusive, diverse network through membership management for its region; how the RML will collaborate with and support other RMLs, NNLM Offices and Centers, and the NNLM Evaluation Center; how the RMLs will collaborate with other RMLs, NNLM Offices and Centers, and the NNLM Evaluation Center to achieve continuity of service during large-scale threats, disasters, and localized emergencies.

Research Strategy:

Development and Support of NNLM Members within the Region: Explain strategies to build upon the NNLM collaborative efforts to develop and support network membership within the region. Plans should address:

• Membership management strategies, from recruitment to consistent engagement promoting active participation in regional or national activities by members in the region, for current and potential NNLM members. Specifically, address how the RML will use bidirectional communication channels and other methods to inform regional activities and the recommendations for the overall NNLM program.
• Collaboration strategies for working with other RMLs, NNLM Offices and Centers, the NLM, and the SC to plan, promote, implement and evaluate national NNLM membership management programs, services, and tools.
• Timeline and milestones for the RML to maintain current members, and to identify and recruit new Network member organizations that represent the diversity and characteristics of the region, from libraries, to information centers, to community-based organizations, to other types of organizations that may support NNLM goals and benefit from membership. Describe what new opportunities exist for NNLM membership recruitment, to support the RML in meeting NNLM’s main goals.
• How the RML will work collaboratively with other RMLs, NWSO (see below), and other NNLM Offices and Centers to maintain the NNLM membership directory so that it is accurate and up to date for the grant cycle.
• Strategies for monitoring the regions membership management program to measure success and to identify and resolve problems which impede the effective delivery of biomedical and health information services.
• Describe plans to use the tools and guidelines developed by the NNLM Evaluation Center to target and measure success, to provide the SC with regular feedback, and to participate in the review of the regional program.

Preparedness & Response Planning: The RMLs, NNLM Offices and Centers, and NLM work together to: ensure continuity of access to health information and effective use of libraries during large-scale threats, both acts of nature and humans; provide assistance to its members in preparing for and responding to disasters or localized emergencies; and help with all emergency preparedness and response activities, including risk assessment, mitigation, education, and developing a regional preparedness & response plan.

Describe the strategy to develop, maintain the readiness, and implement, if necessary, a regional preparedness & response plan, including serving as back-up for NLM customer service inquiries during regional or national emergencies.

Letters of Support: Do not repeat letters that have been submitted in other components. Letters should state the institutional support for being part of NNLM in relationship to the Administrative Core. State how the applicant institution and any partner institutions anticipate participating in NIH programs using subcontracts.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

Delayed Onset Study

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

When preparing your application, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• The Biographical Sketch should reflect the expertise of the individual(s) proposed to manage the RML’s collaborative efforts to support access to biomedical and health information, especially as it relates to: document delivery and interlibrary loan; support of biomedical big data plans, data plan management and data repositories, and management of outreach and education programs

Budget forms appropriate for the specific component will be included in the application package.

The direct costs per year for the Administrative Core and the RML Program Core combined should be no more than $975,000. The budget will depend on regional needs, and the proposed regional and national activities.

The expectation is that administrative operations and costs detailed in this section are streamlined to make the majority of RML funds available for supporting access to biomedical health information, outreach and educational activities.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: : Describe the specific aims for: ensuring that the variety of users, such as librarians, researchers, affiliated and unaffiliated health professionals, public health workforce, educators, and the public, will have equal access to biomedical, health, and public health information and data; and accomplishing NNLM’s main goals to work through libraries and other members to support a highly-trained workforce for biomedical and health information resources and data, improve health literacy, and increase health equity through information. Not all communities have access to the Internet, or the skills to access or interpret biomedical or health information so please describe how you will serve these audiences impacted by the digital divide. Describe the specific aims that address how the RML will continue, develop, implement, improve, and evaluate the impact of outreach, engagement, and education programs that enable NNLM members to bring biomedical, health, and public health information resources and data to researchers, health professionals, the public health workforce, educators, and the public.

Research Strategy:

Plans should include: timelines and milestones for continuing, improving and supporting access to biomedical, health, and public health resources and data; providing regular feedback to the SC; and participating in the review of the regional and national programs. A predominant component of this program is to provide regional and national outreach, engagement, funding, and training on NLM biomedical and health resources, data, and services to help a variety of users, with a focus on reaching underrepresented populations and the health professionals who serve them. NLM seeks to increase the health equity of individuals, their families, and their communities by providing community-driven innovative approaches and interventions through information access. Health equity refers to the equal access to the highest level of health regardless of an individual or community s demographics.

A second component is support of NLM’s DOCLINE system through the DOCLINE Coordination Committee (DCC) a standing committee of the SC, and day-to-day support of DOCLINE users within the region. The committee includes representation from each RML, the NNLM Training Office (NTO), and NLM staff from OET and the NLM DOCLINE team. The DCC will coordinate efforts to provide interlibrary loan services as outlined in the NNLM Organizational Workbook; work with NTO to develop, coordinate and provide DOCLINE user education; identify new candidate DOCLINE participants and continue support for current participants in the region; coordinate national and regional efforts to provide DOCLINE user support; provide feedback to the NLM DOCLINE product owners; and evaluate the effectiveness of these efforts.

A third component is incorporating programs and activities enabling a diverse workforce to support data-driven research and promoting data literacy. The range of challenges and opportunities in this area is outlined in the NLM Strategic Plan 2017-2027.

RML plans should address the following:

• Using innovative methods and participatory approaches to maintain, develop, and implement an outreach and engagement program that is responsive to regional needs. Address how approaches provide an NLM presence in communities throughout the region.
• Engaging NNLM members in the region to carry out the mission and goals of the network. Specifically, address strategies for building, developing, and maintaining relationships with NNLM members and partners.
• Translating national NNLM goals or initiatives for implementation in the region.
• Approaches to contribute to the development and implementation of national and multiregional initiatives.
• Promoting awareness and use of health information resources and data by developing collaborations with organizations serving health professionals, public health workers, and the public. Particular focus should be placed upon organizations that serve underrepresented populations, promote health literacy, and seek to increase health equity by reducing health disparities.
• Processes for announcing, reviewing, and awarding funding/subawards to NNLM members in the region for programs, projects, and activities that support of NNLM’s goals. Include plans for soliciting applications from organizations that have not received funding in previous years and plans for disbursing awards throughout the region. Also describe approaches for subaward monitoring for performance and meeting reporting requirements.
• Contributions to the national education program on biomedical and health information and data in collaboration with other RMLs and NNLM Offices and Centers, under the leadership and coordination of the NTO (see below). The program should include assisting NTO with regular needs assessments of key audiences. The program should incorporate culturally and linguistically appropriate resources.
• Implementing a regional education program that complements the national program to meet special regional needs. The program should incorporate culturally and linguistically appropriate resources.
• Participation in the DOCLINE Coordination Committee (DCC) and provision of customer support for DOCLINE users in the region.
• Advancing access to and use of tools for data-driven research and building a workforce for data-driven research and health within scope of the NNLM program and as articulated in the NLM Strategic Plan 2017-2027.
• Developing, delivering, and evaluating a technology improvement program for NNLM members in the region, health professionals, and the public (with special emphasis on the digital divide), especially as it relates to upgrading and maintaining technology to ensure access to high quality health information.

Plans should include: timelines and milestones for continuing, enhancing, and creating new outreach, engagement, and education programs; how services will be monitored and evaluated; use of tools and guidelines developed by the NNLM Evaluation Center for measuring success; providing regular feedback to the SC; and participating in the review of the regional program.

Letters of Support: Do not repeat letters that have been submitted in other components. Letters should state the institutional support for being part of NNLM in relationship to the RML Program Core. State how the applicant institution and any partner institutions anticipate participating in NIH programs using subcontracts.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When preparing your application, use Component Type NNLM-Office.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Biographical Sketch should reflect the expertise of the NWSO Project Lead proposed to manage and administer day-to-day operations especially: grant management, experience in preparation and management of budgets; writing skills; and, experience in interpersonal and inter-organizational relations. Include proficiencies related to system and account administration; database management; requirements development; policy development; technology direction; project coordination; outsourcing supervision; technical consulting; and system security administration.

Budget forms appropriate for the specific component will be included in the application package.

The direct costs per year for NWSO should be no more than $398,000.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Concisely state specific aims describing how the NWSO will develop and maintain reliable Web services for NNLM public and internal needs, while ensuring that services are compliant with the U.S. Department of Health & Human Services Information Policies (https://www.hhs.gov/web/policies-and-standards/index.html).

Research Strategy:

Describe the organizational and governance structure and provide an organizational chart.

Describe plans for the NWSO to:

• Develop and maintain reliable Web services for NNLM public and internal needs, including, but not limited to: a public website ; membership directory and customer relationship management (CRM); staff intranet; tools for data collection, warehouse (for legacy and operational data), reporting, analysis (e.g., JupyterHub), and visualization (i.e., Tableau and ESRI); and course/training systems (i.e., catalog, registration systems, course/learning management system, and learning objects repository).
• Identify, implement and evaluate information systems security tools appropriate to protecting NNLM information resources in accordance with the U.S. Department of Health & Human Services Information Policies.
• Critically assess and continuously improve the technical architecture of NNLM Web services and maintain modern, up-to-date Web services.
• Work collaboratively and maintain regular channels of communication with the RML, Office, and Center staff who are responsible for web content, especially regarding critical issues and updates affecting NNLM Web services.
• Support the implementation of the DOCLINE Coordinating Committee (DCC) and regional preparedness & response plans.
• Identify software to be used by RML, Office, and Center staff and assist them with selection and implementation of appropriate emerging technologies.
• Coordinate archiving of NNLM data and systems architecture, as appropriate.
• Collaborate with relevant RMLs, Offices, and Centers to develop, maintain, and support NNLM web systems and tools, as appropriate.
• Provide overall content management of the nnlm.gov website.
• Plans should include: timelines and milestones planned to develop and maintain reliable Web services for NNLM public and internal needs; how services will be monitored and evaluated; use of tools and guidelines developed by the NNLM Evaluation Center to develop metrics and measure success; the NWSO Project Lead serving on the SC and providing regular feedback to the SC

Letters of Support: Do not repeat letters that have been submitted in other components. Letters should state the institutional support for being part of NNLM in relationship to the Administrative Core. State how the applicant institution and any partner institutions anticipate participating in NIH programs using subcontracts.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

Delayed Onset Study

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.

When preparing your application, use Component Type NNLM-Office.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• Without duplicating information contained in the biosketches, explain the expertise of the individual(s) proposed to manage the NTO and administer day-to-day operations especially: grant management, experience in preparation and management of budgets; writing skills; and experience in interpersonal and inter-organizational relations. The expertise to assess NNLM educational needs in target audiences, define goals, and identify existing materials, resources and services to coordinate the NNLM education program. Include experience in program management, and experience in adult education instructional design and evaluation models.

Budget forms appropriate for the specific component will be included in the application package.

The direct costs per year for NTO should be no more than $531,000.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Concisely state specific aims to address how the NTO will plan, create, share, deliver, coordinate, and evaluate an instructional program and educational materials based on key NLM products and services for a variety of audiences. NNLM primary audiences include librarians, health professionals, and consumers. Aims should also address how NTO will assess and ensure a standard of high-quality for NNLM instructors and instructional content.

Research Strategy:

Describe the organizational and governance structure and provide an organizational chart.

Describe plans for NTO to:

• Create and implement a national education program for key NLM products and services and coordinate the instructional efforts of NNLM trainers. Plans should include: methods to work with, RMLs, NNLM Offices and Centers, and OET to identify, , develop, implement, evaluate, and maintain NLM training; strategies to reach target NLM training audiences using appropriate strategies and platforms. All materials must follow the U.S. Department of Health & Human Services Information Policies, including being compliant with Section 508. Materials should also be culturally and linguistically appropriate.
• Market and promote training activities and instructional materials created by the NTO, RMLs, Offices, Centers, OET, and NNLM subawards.
• Provide assistance in course development and instructional design to NNLM trainers.
• Maintain instructional standards and the NNLM Guidelines for Classes. Work collaboratively with RMLs, Offices, and Centers to ensure the Guidelines are implemented and standards are met.
• Collaborate with NWSO on the maintenance and enhancement of NNLM training support systems, including: the online registration system, searchable event calendar, learning/course management center, and Learning Objects Repository.
• Monitor and evaluate the effectiveness of the NNLM training program, in coordination with the NNLM Evaluation Center.

Plans should include: timelines and milestones for creating, maintaining and evaluating the NTO, providing regular feedback to the SC; and delivering annual budget and activity reports to the OET.

Letters of Support: Do not repeat letters that have been submitted in other components. Letters should state the institutional support for being part of NNLM in relationship to the NTO. State how the applicant institution and any partner institutions anticipate participating in NIH programs using subcontracts.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

Delayed Onset Study

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

be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type NNLM-Office.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Biographical Sketch should reflect the expertise of the Project Lead proposed to manage and administer day-to-day operations especially: grant management; experience in preparation and management of budgets; writing skills; and experience in interpersonal and inter-organizational relations. Include knowledge of information products and services desirable for public health workers, and experience with providing access to licensed, trusted information and e-resources.

Budget forms appropriate for the specific component will be included in the application package.

The direct costs per year NPHCO should be no more than $ 341,000.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Public health departments rely on evidence for the effectiveness of interventions to make key decisions about programs, practices, and policies that promote health in their communities. The public health workforce needs the tools and skills to effectively integrate research and data into public health management and practice. The NNLM Public Health Coordination Office (NPHCO) will enhance the public’s health by expanding NNLM’s engagement with the diverse public health workforce. This will be accomplished by providing health information access to public health departments, including licensed literature and content; developing and coordinating training on NLM resources, services, and data for the public health workforce; and facilitating partnerships between RMLs, NNLM members, and public health departments.

Concisely state specific aims to: manage, improve, and achieve a cost-effective, sustainable model of providing access to information to the public health workforce; facilitate partnerships between public health departments, RMLs, and NNLM members, specifically academic and public libraries; assess current and emerging information needs in public health including biomedical information, public health informatics, clinical information, and data science techniques and tools; and, coordinate and expand training delivered to the public health workforce in these information areas.

Research Strategy:

Describe the organizational and governance structure and provide an organizational chart. The NPHCO program has information access, training, and engagement components.

Describe plans for NPHCO to address information access by:

• Proposing innovative approaches to information access based on the needs of the public health workforce with the aim to achieve a cost-effective, sustainable model for providing information services to public health departments.
• Regularly assess current and emerging information needs in public health related to biomedical and health information.
• Providing access to relevant literature and information for state, local, tribal, and territorial public health departments. Describe strategies to increase efficiency and sustainability of the information access plan; examine economies of scale and sharing agreements; and implement a cost-recovery model for the Office.

Describe plans for NPHCO to address training by:

• Collaborating with NTO to enhance or create online and on-demand trainings using existing NNLM training assets that address public health workforce information needs. Trainings will be delivered by NPHCO and RML staff to end-users. These needs include evidence-based public health research, skills to enhance the utilization of NLM biomedical resources, and data science skills and applications for public health.
• Coordinating and expanding NNLM training to the public health workforce in collaboration with the RMLs, Offices, and Centers, including development and delivery of classes for the public health workforce and serve as subject matter experts to RMLs, Offices, and Centers.
• Utilizing TRAIN Learning Network to expand the reach of NNLM trainings to the public health workforce.
• Describe plans for NPHCO to address engagement by:
• Connecting and facilitating partnerships between RMLs, public health departments, and academic and public libraries.
• Providing leadership and coordination of a national public health services program with the RMLs, and other NNLM Offices and Centers. Describe strategies to expand the reach of NNLM to the public health workforce and processes to ensure RMLs, and Offices and Centers are informed about the information needs of the public health workforce.
• Identifying and approaching potential partners, both public and private, that could assist in accomplishment of specific aims. Potential partners include the U.S. Centers for Disease Control and Prevention (CDC), National Association of County and City Health Officials (NACCHO), the Public Health Foundation (PHF), and the Public Library Association (PLA).

Plans should include: timelines and milestones designed to improve and expand the NPHCO; how the NPHCO will be monitored and evaluated; use of tools and guidelines developed by the NNLM Evaluation Center to measure success; the NPHCO Project Lead serving on the SC and providing regular feedback to the SC; and participation in review of the NPHCO information access services

Letters of Support: Do not repeat letters that have been submitted in other components. Letters should state the institutional support for being part of NNLM in relationship to the NPHCO. State how the applicant institution and any partner institutions anticipate participating in NIH programs using subcontracts.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

Delayed Onset Study

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

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) using ASSIST or other electronic submission systems. 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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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 (SAM). 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 impact score for each required component of the RML (Overall, Administrative Core, and RML Program Core) and for the optional NNLM Offices (NWSO, NTO, and NPHCO). Reviewers will provide individual criterion scores for the Overall component, but not for the other components. The Overall impact score will be derived from the impact scores for all components of this application. The Overall impact score may be higher or lower than the average of the scores for the individual components based on assessment of whether the whole is greater than the sum of its cores. Reviewers will discuss and provide written critiques for all the application components.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the RML 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 RML that by its nature is not innovative may be essential to advance a field.

Does the RML 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 RML 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?

Will the RML promote the mission of the Network of the National Library of Medicine? Will a variety of users, including underrepresented populations have equal access to biomedical, health, and public health information and data? Does the proposal focus on working through libraries and other members to support a highly-trained workforce for biomedical and health information resources and data, improve health literacy, and increase health equity through information? Will successful completion of the aims improve the concepts or methods for biomedical and health information, and/or data access?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the RML? 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 RML? Have 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?

If the RML 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?

Do plans for leveraging partners and partnerships show unique capabilities for the program? Do those plans demonstrate the ability to adequately respond to regional and national needs? Do the plans demonstrate a broad understanding that all groups within the region require equal access to the highest level of health information regardless of an individual or communities demographics? Will the plans for management and oversight of the RML, including plans to define meaningful measures of success, monitor and analyze progress, and use the tools and guidelines developed by the NNLM Evaluation Center, result in a high quality, efficient program? Will the RML collaboratively build and maintain an inclusive, diverse network through membership management for its region?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the RML 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.

Overall Coordination and Integration

Does the overall organizational chart clearly present an overview of the performance sites, data analysis and data management functions and responsibilities of the Administration Core, RML Core?

Are the roles clearly defined and divided among the different entities? Are there adequate mechanisms for regular communication among project leaders and collaborators?

Is there an adequate plan to ensure that all subawards are meeting the performance objectives for the RML and NNLM?

Will the RML function as an effective regional center or hub rather than a collection of unrelated services and activities? Will there be coordination, interrelationships, and synergy among the RML projects and programs and the NNLM as a whole?

Milestones and Timeline

Are clear, actionable milestones and timelines proposed to establish the RML, 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 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.

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.

For Renewals, the committee will consider the progress made in the last funding period.

Not Applicable

As applicable for the RML 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.

As applicable for the RML 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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Administrative Core to exert a sustained, powerful influence on the research and service field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the core proposed).

Reviewers will consider each of the criteria below in the determination of scientific and technical merit.

• Is the administrative and organizational structure appropriate and adequate to the attainment of the objectives of the RML?
• Does the proposed RML Director (i.e., PI/PD) have the experience in leadership required for a program of this scope?
• Does the proposed organizational structure, governance and expertise (or position descriptions) of staff reflect the needs required of a program of this scope?
• Is the management plan for fiscal accountability and communication between the RML and their grants/financial office appropriate?
• Are the plans for coordination, problem identification and resolution, and the establishment of a strong collaborative environment for the RML appropriate?
• Does the plan explain strategies for how the RML will collaboratively build an inclusive, diverse network through membership management for its region?
• Is the plan for how the RML will collaborate with and support other RMLs, NNLM Offices and Centers, and the NNLM Evaluation Center adequate?
• Does the plan explain strategies to maintain the readiness and implement, if necessary, the regional preparedness & response plan, including serving as back-up for NLM customer service inquiries?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the RML Program Core to exert a sustained, powerful influence on the research and service field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the core proposed).

Reviewers will consider each of the criteria below in the determination of scientific and technical merit.

• Are the plans adequate for addressing how the RML will continue, develop, implement, improve, and evaluate the impact of outreach, engagement, and training programs that enable NNLM members to bring biomedical, health, and public health information resources and data to researchers, health professionals, the public health workforce, educators, and the public?
• Will the plans for regional and national outreach, engagement, funding, and training on NLM biomedical and health resources, data, and services to help a variety of users result in a high-quality, efficient program? Is the approach viable for reaching underrepresented populations and the health professionals who serve them? Do the plans demonstrate a broad understanding of achieving health equity through information access?
• Is the plan for translating national NNLM goals or initiatives for implementation in the region feasible? Does the program explain how culturally and linguistically appropriate resources will be incorporated and used to achieve the specified aims?
• Does the program provide effective approaches for developing collaborations to advance access to and use of tools for data-driven research and building a workforce for data-driven research and health? Did the applicant identify organizations serving health professionals, public health workers, and the public that could support the goal, particularly those that serve underrepresented populations, promote health literacy, and seek to increase health equity through information?
• Is the approach adequate for participation in the DOCLINE Coordination Committee (DCC) and provision of customer support for DOCLINE users in the region?
• Does the proposed program address how the RML will develop, deliver, and evaluate a technology improvement program?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the NWSO to exert a sustained, powerful influence on the research and service field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the NWSO proposed).

Reviewers will consider each of the criteria below in the determination of scientific and technical merit.

• The effectiveness and relevance of the organization’s history of providing similar services and development of new technologies or other significant advances;
• Is the plan to critically assess and continuously improve the technical architecture of NNLM Web services and maintain modern, up-to-date Web services adequate and feasible?
• Does the proposed program adequately describe how NWSO will develop and maintain reliable Web services for the full range of NNLM public and internal needs? Will the plan ensure that services are compliant with the U.S. Department of Health & Human Services Information Policies?
• Does the proposed NWSO Project Lead have the experience in leadership required for a program of this scope?
• Does the experience of the individuals proposed (or position descriptions) adequately reflect the needs to effectively implement the NNLM public and internal Web services?
• Is the plan to implement and evaluate information systems security tools appropriate to protecting NNLM information resources in accordance with the U.S. Department of Health & Human Services Information Policies adequate?
• Does the program plan describe an effective approach to work collaboratively with and maintain channels of regular communication among the RML and NNLM Offices and Centers staff who are responsible for Web presences, especially regarding critical issues and updates affecting NNLM Web services?
• Are the plans adequate to: coordinate the archiving of NNLM data; support the DOCLINE Coordinating Committee (DCC); and support the implementation of the regional preparedness & response plans?
• Is the plan to identify software to be used by RML and NNLM Office and Center staff and assist them with selection and implementation of appropriate emerging technologies adequate and feasible? Will the strategies for collaboration with RMLs, other NNLM Offices and Centers be effective?
• Has the applicant provided a viable plan to provide overall content management of the nnlm.gov website?
• Does the plan to develop and maintain reliable Web services for the NNLM public and internal needs detail the development of sound timelines and milestones, evaluation methods and reporting strategies?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the NTO to exert a sustained, powerful influence on the research and service field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the NTO proposed).

Reviewers will consider each of the criteria below in the determination of scientific and technical merit.

The effectiveness and relevance of the organization’s history of providing similar services and development of new technologies or other significant advances;

• The effectiveness and relevance of the organization’s history of providing similar services and development of new technologies or other significant advances.
• Continuity of quality service for core programs of the NNLM, and the design, implementation and evaluation of innovative future approaches.
• Does the proposed Project Lead have the experience in leadership required for a program of this scope?
• Does the proposed organizational structure, governance and expertise (or position descriptions) of staff reflect the needs required of a program of this scope?
• Does the proposed program address how the NTO will plan, create, share, deliver, and coordinate an Instructional program and training materials based on key NLM products and services for a variety of audiences?
• Does the applicant explain how it will assess and ensure a standard of high-quality for NNLM instructors and instructional content? Does the plan for national coordination address methods to work with RMLs, other NNLM Offices and Centers, and OET to identify, evaluate, recommend, develop, implement, and maintain a core curriculum of NLM training, instructional materials, and training programs;
• Has the applicant provided a viable approach for developing materials that are complaint with the U.S. Department of Health & Human Services Information Policies, including being compliant with Section 508, and culturally and linguistically appropriate?
• Are the plans adequate for collaborating and partnering with other organizations; marketing and promoting training activities and instructional materials; providing assistance in course development and instructional design; and maintaining instructional standards and guidelines?
• Is the plan feasible to collaborate with NWSO on the maintenance and enhancement of NNLM training support systems, including: the online registration system, searchable event calendar, learning/course management center, and Learning Objects Repository or equivalent?
• Does the plan include sound timelines and milestones, development of metrics, assessment and evaluation methods, and reporting strategies?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the NPHCO to exert a sustained, powerful influence on the research and service field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the NPHCO proposed).

Reviewers will consider each of the criteria below in the determination of scientific and technical merit.

• The effectiveness of the organization’s history of providing similar services and development of new technologies or other significant advances;
• Continuity of quality service for core programs of the NNLM, and the design, implementation and evaluation of innovative future approaches.
• Does the proposed program address plans to manage, improve, and achieve a cost-effective, sustainable model of providing access to information to the public health workforce?
• Does the proposed Project Lead have the experience in leadership required for a program of this scope?
• Do the proposed organizational structure, governance and expertise (or position descriptions) of staff reflect the needs required of a program of this scope?
• Will the plan for information access result in a cost-effective, sustainable modell?
• Does the program plan demonstrate a broad understanding of the training delivery needs of the public health workforce and TRAIN Learning Network?
• Does the proposed program explain how partnerships between RMLs, public health departments, and academic and public libraries will be established?
• Does the plan detail the development of sound timelines and milestones; monitor and evaluate the project; develop metrics, assessment and evaluation methods to measure success, and report strategies?

Budget and Period of Support

For each optional NNLM Office component (NWSO, NTO, and NPHCO) reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed Office. However, reviewers will not give scores for budgetary items or 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 .

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 NLM in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NLM Board of Regents. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides 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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. 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 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• 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.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) 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:

• Retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
• Assess and evaluate project and program activities in accordance with applicable guidance in the NNLM guidelines and procedures documents.
• Ensure publications and presentations of work performed under this Cooperative Agreement have appropriate acknowledgement of NLM support. Timely publication of major findings is encouraged.
• Provide, in addition to standard annual progress reports, other relevant information to the NNLM PS(s), PC, or PO and coordinate and cooperate with OET staff, and other members of appropriate collaborating NLM programs.
• Work directly with the PS(s) and PC on the coordination of NNLM program activities and the integration of individual projects within the NNLM as well as with other relevant NLM programs.
• Participate in meetings, work groups, and training as needed to plan and accomplish the goals of the NNLM.
• Actively participate as a voting member of the NNLM Steering Committee.
• Accept and implement all procedural and policy decisions approved by the Steering Committee (SC) in addition to applicable NIH policies, laws, and regulations.

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 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):

• Cooperate or coordinate with, or provide assistance to, awardees in performing project activities, e.g., development of projects; data collection, analyses, and interpretation; and re-establishment of objectives during the course of a project;
• Provide for an option to halt a project activity if technical performance requirements are not met or if program objectives have already been met;
• Specify under the terms and conditions of award that the project be structured in stages and that NIH staff review and approve each stage before work may begin on such stage;
• Provide technical monitoring to permit specific direction of the project, including recommending approval of changes in approaches;
• Participate on the Steering Committee (SC) as a nonvoting member as needed (the chairperson will be someone other than an NLM staff member) or in other functions responsible for helping to guide the course of long-term projects or activities; and
• Participate in the presentation of research results, including publications from the project.

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 program to ensure effective and efficient performance of the aims and mission of the NNLM.

• Cooperation or coordination with, or assistance to, awardees in performing project activities, e.g., coordination of program networks; providing access to NIH supported resources; identifying other participants/resources for the project;
• Participate on committees as a voting member (the chairperson will be someone other than an NLM staff member) or in other functions responsible for helping to guide the course of long-term projects or activities, e.g., annual meetings of awardees, Chair and/or member of project oversight committees composed of NIH officials.

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. Normal PO stewardship includes:

• Enforcement of general statutory, regulatory, or policy requirements;
• Approval of awardee plans prior to award and review of performance after completion;
• Programmatic review of prior approval requests;
• Evaluation of progress by reviews of technical or fiscal reports, site visits, or external consultants, to determine that performance is consistent with the terms and conditions of the award;
• Technical assistance requested by awardees, or unanticipated procedures to correct programmatic or financial deficiencies in awardees' performance;
• Scientific/technical discussions with awardees, or actions to facilitate or expedite interactions between awardees, e.g., organizing and holding meetings of investigators.

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 activities and the integration of individual projects with other appropriate NLM programs. Joint responsibilities include:

• Developing collaborative working groups to reduce duplication of effort and maximizing efficiencies.
• Organizing and conducting regular meetings to share progress and foster collaborations within NNLM, by teleconference, virtual meeting, or face-to-face, as needed.
• Developing and implementing strategies for evaluating and reporting the effectiveness of the NNLM.

Steering Committee(SC)

The Steering Committee (SC) will provide overall integration among NNLM RMLs, Offices and Centers, 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, 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 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.

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

A final 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 agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission 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)

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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 Federal Regulations 42 USC 286b-6 and under Federal Regulations 42 CFR Part 59a?.