NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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

The objective of the NIDDK Cooperative Specialized Hematology Core Centers (CHSCC) is to bring together investigators from different, yet relevant, disciplines to enhance and extend the effectiveness of the NIDDK Hematology research mission. A Core Center could be an identifiable unit within a single university medical center or a consortium of cooperating institutions, including an affiliated university. The overall goal of the NIDDK CHSCC program, using the U54 cooperative agreement activity, is to bring together pre-clinical and basic science investigators in a manner that will enrich the effectiveness of nonmalignant hematologic diseases research at the institutional and national levels.

The purpose for developing CHSCCs as an organizational mechanism is to promote the joint efforts of both basic scientists and pre-clinical researchers. In an effort to broaden the scope of Core facility expertise covered by the CHSCC Consortium, NIDDK is seeking additional Centers to complement the existing Core facilities. Research areas engaged by an NIDDK CHSCC should be in line with the research mission of the NIDDK Hematology program (see: http://www.niddk.nih.gov/research-funding/research-programs/Pages/default.aspx#category=hematologic-disease.)

Some of the areas already supported by Biomedical Core facilities are:

• Hematopoietic Stem Cell (CD34+) Cell procurement and processing
• Intravital microscopy
• Super resolution microscopy
• Large animal (canine) modeling of hematopoiesis

NIDDK is currently seeking CHSCCs with complementary Core facilities that may include (but are not limited to):

• CRISPR/Cas9 technology support
• Erythroid cell biology/physiology; globin gene regulation; hemoglobin synthesis
• Nonmammalian models of hematopoiesis
• Innovative xenograft recipient models
• Hematopoietic cell physiology; blood cell receptor biology, growth factors and signaling
• Myeloid/erythroid cell reagents
• Iron metabolism; pathophysiology of iron overload
• Computational biology or Bioinformatics applications to hematopoiesis

An existing biomedical research program of excellence in an area of nonmalignant hematologic diseases and disorders is required. This research base must be extramurally supported through federal or non-federal grants or contracts and active at the time of application submission. Key Personnel in the research base should have a history of close cooperation, communication, and collaboration.

Furthermore, the research base should provide a foundation and nucleus for enhancing and expanding Center activities. It should provide a backbone of support for the enrichment of early stage investigators who are just beginning a research career in nonmalignant hematology. Members of the research base are expected to be role models for the next generation of NIDDK hematology researchers and to provide mentorship, career guidance and scientifically sound advice on new ideas proposed within the CHSCC environment. The ultimate goal of research applications stimulated by Center activities should be the development of preventive, curative, or interventional strategies in the treatment of nonmalignant hematologic diseases.

Applicants should consult with the NIDDK Scientific/Research staff listed below concerning plans for the development of a Center and on the organization of the application.

The NIDDK CHSCCs are based on the Core concept. A minimum of three and up to six Cores may be included in an application. Cores are defined as shared resources that enhance productivity, provide uniform quality control, impart an economy of scale or in other ways benefit a group of investigators working to accomplish the stated goals of the Center. Reagents, resources or expertise associated with at least two Cores at each Center should provide unique functions (not present in any existing Centers) and be made available nationally with easy (facilitated) access to the greater nonmalignant hematology research community. The remaining Core(s) may predominantly serve local investigators, but should continue to demonstrate 'value added' to the Center's research base.

Multi-institutional domestic applications are encouraged. Such applications should have a history of collaborations among investigators as demonstrated by co-authored publications, grant applications proposing projects with combined expertise of investigators, or other such evidence of collaboration.

Besides the Administrative and Research Cores, two other types of activities must also be supported with Center funding: a Pilot and Feasibility (P and F) program and an Enrichment Program. The P and F program provides modest short-term support for new initiatives or feasibility research. This program is directed at early stage investigators, at investigators established in other research disciplines with expertise that may be applied to hematologic disease research, and, occasionally, at investigators already working in hematologic diseases who wish to make a substantial change in the direction of their research. By establishing ties with an institution's existing resources, such as a Clinical and Translational Science Award (CTSA), the P and F program funds might be leveraged more effectively to pursue such projects.

The NIDDK CHSCC application may include limited funds for program enrichment such as seminars, visiting scientists, consultants, and workshops.

The presence of a Center, with the resources it provides, should enrich any institutional training efforts and should be a positive factor when recruiting postdoctoral fellows and junior faculty. Likewise, trainees should be able to generate highly competitive preliminary data to include in a future NIDDK Hematology grant application.

The NIDDK CHSCC program will consist of Centers that will work together with the NIDDK under a cooperative agreement. Center Directors are expected to work with NIDDK staff to promote and facilitate research collaborations within and between the Centers and with the wider research community. The ultimate goals are to develop a national network that accelerates application of laboratory research to the clinic, to stimulate investigation into the pathophysiology of hematologic disorders observed in the clinic and to discover and develop new therapies for nonmalignant hematologic diseases.

Components of the CHSCC should reflect the overall goal of the Center, encourage collaboration, and promote the use of shared resources and P and F funds.

Administrative Core

The Administrative Core of a CHSCC will be responsible for coordinating and integrating the various components. This Core should have a process to a) assess the productivity, effectiveness, and appropriateness of Center activities; b) determine criteria and selection process for Center membership; and c) foster collaborations and scientific opportunities among its members. Each CHSCC will be required to create and maintain a CHSCC-specific website, take responsibility for its curation and oversight as well as ensure proper and seamless integration of the Center website with the NIDDK Centers website.

Biomedical Research Cores

A CHSCC is designed around Research Cores that provide shared, specialized technical resources and/or expertise to enhance the efficiency, productivity, and multidisciplinary nature of research performed by the Research Base. Cores should be designed to furnish a group of investigators with some technique, assay, expertise or instrumentation that will enhance reproducibility, efficiency, and cost effectiveness.

Each Research Core should provide state-of-the-art services to multiple, funded research projects. Cores may be located at different institutions and, if so, should focus on the overarching theme and purpose of the CHSCC. Cores are not meant to supplant investigator capabilities, but rather to enhance them and provide opportunities for investigators and their staff to learn and then become proficient in the technologies available through the Core. Teaching investigators and/or their staff is an important function of a Core.  There should be quality control incorporated into the Core processes.

Pilot and Feasibility Program (P and F)

The NIDDK CHSCC P and F program provides seed support for new and innovative research projects directed at research topics within the NIDDK Hematology program as delineated in the Purpose section. The P and F program is particularly directed at Early-Stage Investigators (ESIs) or to established investigators new to nonmalignant hematology research. Established nonmalignant hematology researchers pursuing new lines of research within the NIDDK hematology mission that are significant departures from their usual work are also eligible for support under the P and F program. P and F projects may also be structured to provide support for establishing interdisciplinary collaborations and to help forge new partnerships. Applications for individual P and F projects will be managed, reviewed and selected for awards by the PD/PI with advice from NIDDK CHSCC Steering Committee.

Enrichment Program

The NIDDK CHSCC can provide support for enrichment activities to foster collaborations. Support for visiting scientists, exchange programs between Centers for postdoctoral fellows, seminars and research fora are appropriate items for inclusion in an enrichment program. Besides instruction in grant-writing skills, other career enrichment activities may be included, such as training on how to manage a laboratory, how to publish a paper in a peer-reviewed journal, how to negotiate a faculty position, etc. In addition, travel support may be requested to allow Core Center investigators to travel to present scientific findings, to learn new laboratory techniques, to develop new collaborations or to engage in scientific information exchanges.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

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

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

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

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

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

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

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

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

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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

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

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

The letter of intent, preferably electronically, should be sent to:

Dr. Francisco O. Calvo
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5254
Telephone: 301-594-8897
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core	6
Core (Use for each Biomedical Research Core)	6
PilotandFeasibility (Use for Pilot and Feasibility Program)	12
Enrichment Program	12

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
• Biomedical Research Cores: Required: at least 3, but no more than 6. NOTE: Cores will be listed in the final application in the order they were entered into ASSIST.
• Pilot and Feasibility program: Required
• Enrichment program: Required.

When preparing your application in ASSIST, 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. Please include additional information for the fields described below:

Project Summary/Abstract: Describe the scientific theme, goals, and objectives of the Cooperative Hematology Specialized Core Center and how these contribute to accomplishing the overall goals of the NIDDK Hematology program. Describe the need for a Center to support the investigators in the research base. Explain the overall strategy for achieving the goals of the Center. Include the number and a brief description of the Center members and the overall direct costs present in the research base. Provide a brief overview of the research base as it relates to the theme of the Center, as well as an overview of the biomedical research Cores, and the pilot and feasibility and enrichment programs.

Facilities and Other Resources: Briefly describe the existing environment and facilities available to the Center and the process, including fee structure, to access the facilities.

Equipment: A general listing of major, shared pieces of equipment to be used by Center members should be provided and the process, including fee structure, to access shared equipment should be described.

Other Attachments: The following "Other Attachments" should be included with the Overall Component in order to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image.  All attachments should be in pdf format. Samples of Table formats that applicants may choose to use may be found at: http://www.niddk.nih.gov/research-funding/process/apply/about-funding-mechanisms/Pages/U54.aspx), where Tables A refer to the Center's Research Base, Table B refers to Center's Members and Table C refers to Collaborations among Center members.

Grant Support of Research Base - Please give this attachment the title, "Grant Support of Research Base", and include all federal and non-federal grant support related to nonmalignant hematology for CHSCC members who are not Senior/Key Personnel. Complete and organize alphabetically by the last name of the Center Investigator who is listed as the PD/PI on the grant application. Include Supporting Organization/Grant Numbers, Complete Grant Title, Project Period, Annual Direct Costs. The attachment should include, in order: Current Grant Support (Table A.1), Other Grant Support (Table A.2) and Pending Grant Support (Table A.3). Tables A.1, A.2, and A.3 are provided for applicant assistance with this requirement

Biographical Sketches of Center Research Base Investigators - Please title this attachment "Center Research Base Biographical Sketches". Provide biographical sketches for all Center Research Base, as defined by the Center within the application, and organize them alphabetically by the last name of the Research Base Investigator. Do not include biographical sketches for Senior/Key Personnel since those are included with the appropriate component of the application and should not be duplicated here.

Provide a narrative description of no more than one page per research base investigator. These narratives should include the active grant number (s), title(s), and a few descriptive sentences of the investigator's research projects, as well as a brief description regarding what aspect of the investigator's research justifies the use of Center Core facilities. In the description of the research base, include ONLY those grants awarded, or subcontracted, to investigators at the applicant institution or consortium, not to investigators at other locations. It is particularly important to provide a few sentences indicating the relatedness of a cited grant to research in nonmalignant hematology when this is not readily apparent from the project title of the grant.

Description of Center Members - Please title this attachment "Description of Center Members and Core Use" and organize alphabetically by Center Member (last name) in Table B. Specify the Biomedical Research Cores used (or anticipated use) by each Member. If more than one membership category is designated by a Center, then include all membership categories for each Center Member. For each Center Member, indicate those Core facilities that will be used.

Core Use by Center Members - Please title this attachment "Core Use by Center Members" and organize alphabetically by Center Member (last name).

Description of Collaborations between Center Members - Table C must document collaborations and interrelationships of the CHSCC members, including collaborative (co-authored) publications.

Optional: Charts and Tables related to the organization of the applicant institution, such as an organization chart(s) to illustrate the structure, interactions, and leaders of the institution and CHSCC may be included. This should be loaded as a single file titled "Relation to Overall Center".

Specific names provided for Other Attachments must be no more than 50 characters including spaces.

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. The PD(s)/PI(s) must be an established investigator with a record of external funding, but is not required to have a record of accomplishments in nonmalignant hematology.

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: State the overall goals of the CHSCC with both short-term and long-term objectives. Describe the strategy by which the long-term objectives will be reached. The plan should delineate how the CHSCC will enhance ongoing projects, assist in the introduction of outstanding new projects, respond to future challenges and opportunities, and promote collaborations, advances in technology and progress in nonmalignant hematology research.

Research Strategy: Explain the overall strategy for achieving the goals for the CHSCC as defined in the Specific Aims and explain how the Administrative Core, Biomedical Research Cores, Pilot and Feasibility and Enrichment programs relate to that strategy. Explain how the different aspects of the organization, including key personnel will interact, why they are essential to accomplishing the overall goals of the CHSCC, and how combined resources create a Center that is worth more than the sum of its parts. In addition, tell how a Biomedical Research Core's reagents, resources or expertise will be distributed over a large geographical area and well beyond the institution's boundaries.

Research Base

Existence of a strong, substantial research base in nonmalignant hematology research, that is within the NIDDK hematology program mission is a fundamental requirement for the establishment of a CHSCC. Applicants should include an overview of current research in nonmalignant hematology that will form the base of the CHSCC. This may be limited in size due to the focused area of research that is within the NIDDK hematology program, but it may include research activities from other institutions (multi-institutional research base). Nevertheless, applicants should indicate how the establishment of a CHSCC will provide added dimensions, such as greater focus and increased cooperation, communication and collaboration that would not likely occur without CHSCC resources. Justify why the CHSCC is needed for this purpose and the deficiencies that would occur without the CHSCC.

As part of the Research Strategy, provide a full narrative description of the nonmalignant hematology research activities at the applicant institution and any collaborating institutions. The research of each CHSCC participant should be discussed along with interrelationships of research being conducted by other CHSCC participants. The quality of the research base is already vetted through the peer-review process, so there should be a focus on the interactions and interrelationships of the research efforts, uses and benefits of Core services, plans to develop productive collaborations among CHSCC investigators, and how the research base will provide a springboard for the launching of talented postdoctoral fellows or other early-stage investigators.

Criteria for becoming a CHSCC member should be clearly defined. Specific membership criteria, and any affiliation categories (if applicable), should be clearly defined by the applicant in order to better organize and facilitate the focus of the CHSCC's mission. The application should state clearly: a) how CHSCC membership(s) are defined; b) the application and selection processes for Center membership; and c) the obligations of Center membership. Suitable criteria include, but are not limited to, peer-reviewed independent funding, participation in nonmalignant hematology research, and the need for the use of Core facilities or contribution to the overall goals of the CHSCC. A plan to arbitrate failures to meet stated obligations should also be provided.

Administration, Organization, and Operation of the CHSCC

Describe the organizational framework. Include information on the use of advisory or user committees. Do not name individuals who will serve on the committees, but simply describe the process and function of such committees.

Building Research Capacity - Provide details on the special talents and resources that will be drawn to and built upon at the CHSCC. How will these talents be harnessed and used to promote new collaborations and develop productive multi-disciplinary teams to address more complex questions? Different plans should be described for investigators already in the field and for those to be drawn into nonmalignant hematology.

Integration of investigators with multiple skills and talents - Outline steps the CHSCC will take to promote interdisciplinary studies and collaborations. Briefly describe the scientific need and rationale for fostering such integration.

Innovation - Explain how synergy of the CHSCC with the research base will lead to novel services and resources in the Cores and how this synergy could not happen without the CHSCC. Give an assessment of the potential for interdisciplinary collaborations among CHSCC members. Describe plans to overcome roadblocks that might exist in developing such collaborations. Leveraging existing resources is encouraged.

Letters of Support: Include any letters of support for the proposed CHSCC by appropriate institutional officials. Letters should address the commitment of the parent organization, or any of its partners, to the CHSCC. The parent institution is expected to recognize the CHSCC as a formal organizational component and provide documented evidence of space dedicated to the needs of the CHSCC, protected time to devote to CHSCC activities, staff recruitment, dedicated equipment, or other financial support for the proposed CHSCC. The parent institution should provide assurance of its commitment to continuing support of the CHSCC in the event of a change in leadership and provide a well-defined plan for this, should such a change in leadership occur. In addition, it is expected that the institution will support the goal of providing CHSCC members priority access to institutional facilities and services at a minimal or reduced cost. Both the institution and pertinent departments must show a strong commitment to supporting the CHSCC.

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.
• The application is expected to describe a plan for oversight of the Resource Sharing Plan for the entire Center.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, 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 Administrative Director 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.
• One of the PDs/PIs is required to be the Administrative Core Director.

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

Personnel: The CHSCC Director(s) must devote at least a total of 2.4 calendar months to the CHSCC. At least 1.2 calendar months must be within the Administrative Core to ensure adequate oversight of the CHSCC. In a multiple PD/PI application, the combined effort of the PDs/PIs must be 2.4 calendar months. One or more Associate Directors may be named as well, but the combined efforts of the Center and named Associate Directors should not exceed 6 person months effort (equivalent to 50% full-time professional effort).

Consultants: Include costs associated with consultants (consultant fees, per diem, teleconferences and travel) when their services are required by the CHSCC, such as members of the External Advisory board.

Travel: Include the costs of domestic and foreign travel only if the travel is directly related to the activities of the CHSCC. Include travel costs for the Center Director, Associate Director (if employed) and others as appropriate (e.g., Core Directors) to attend the annual CHSCC Directors meeting once per year.

Equipment: If pieces of specialized equipment or computers, costing more than $5,000 are requested, the application must identify similar equipment already available within the institution and provide a clear justification for purchase based on Core service provided to CHSCC members. Requests for general-purpose equipment should be included only after ascertaining the availability of such items within the institution. Justify the request based on this availability. Equipment may only be requested in the initial budget period.

Other expenses: Funds for supporting the CHSCC website may be requested.

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 of the Administrative Core

Research Strategy: Describe the organization of the Administrative Core, including the strategy for achieving the goals for the CHSCC as outlined above. Describe the plan for overseeing the Resource Sharing plan for all CHSCC components.

Describe the strategy by which the Administrative Core will effectively lead, organize, and provide a) fiscal and resource management to the CHSCC; b) provide oversight of the Biomedical Resource Cores, Enrichment Program, and P and F program; c) coordinate the CHSCC's research activities with other CHSCCs and with the greater hematology research community; d) communicate with the general public about the CHSCC activities and e) a seamless working relationship with the administration of the institution.

Outline the approaches to be utilized for internal monitoring, including review of productivity and effectiveness of the activities of the CHSCC and mitigation strategies for replacing CHSCC personnel or ineffective Cores.

Use of an External Advisory Committee is strongly advised. The members of this Committee must not be named in the application or contacted before the application is submitted; however, the process by which members are selected must be described in detail. The External Advisory Committee, consisting of 3 - 5 prominent members of the hematology research community, may advise the Center Director(s) and the CHSCC's Executive committee in the areas of scientific direction, budget, policy, collaborations, or other areas.

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:

• The Resource Sharing Plan in the Overall Center Overview applies to the entire application.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core. Separate 'Core' components should be created for each individual Biomedical Core proposed.

A proposed Biomedical Research Core must be a shared facility that provides specialized and essential services, techniques, or instrumentation to CHSCC members and participants. As the Biomedical Research Core provides specialized technologies and expertise needed to accomplish the stated goals of the CHSCC, the Biomedical Research Core must be used by two or more of the research projects in the Research base and no one project should utilize greater than 50% of the Core services. Biomedical Research Cores may be based solely at the applicant institution or at multiple institutions through subcontracts.

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

SF424 (R&R) Cover (Biomedical Research Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Biomedical Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Biomedical Research Core)

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.

Project /Performance Site Location(s) (Biomedical Research Core)

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.

Research & Related Senior/Key Person Profile (Biomedical Research Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Biomedical Research Core Director' 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.

Budget (Biomedical Research Core)

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

Personnel: Biomedical Research Core Director(s) must devote at least 0.6 calendar months (5% effort) as a Core Director to ensure adequate oversight. The amount of salary charged to the CHSCC must be commensurate with the time spent on CHSCC activities and is subject to institutional and NIH salary policies. A Core Director with requisite expertise may devote a greater effort to the Core, and with strong justification could devote up to 12 calendar months. Salary support for technicians and other Core personnel are allowable in accordance with the volume and type of work in the Core.

Occasionally, Core direction may involve two individuals. In this case, the combined effort of the Research Core Directors must be 0.6 calendar months. Salary for individuals with less than 2.5% effort may not be requested. Such individuals are considered Other Significant Contributors. Also, stipends for research trainees are not available through the CHSCC. Such funding must be sought through other grant mechanisms.

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.

PHS 398 Research Plan (Biomedical Research Core)

Specific Aims: Describe the specific aims of the Biomedical Research Core.

Research Strategy: Describe the purpose and objectives of the Biomedical Research Core and the administration, organization, and operation of the Biomedical Research Core. Include a description of services and/or reagents provided and their role in enhancing productivity, provision of uniform quality control, imparting economy of scale and efficiency. Consider and describe creative ways these reagents, resources or expertise could be made available nationally.

The need for Core support from the CHSCC must be well justified with clear documentation of the user base, as well as an extended user base. Applicants should provide information on other programs supporting related resources at their institution and describe the nature of synergy and integration between the CHSCC and these other activities. Applicants must also clearly describe how duplication or redundancies of effort, services and resources will be avoided. Leveraging of existing resources that provide a range of services or efficiency that would not otherwise be available is also encouraged.

Outline the strategy for deciding how access to the Biomedical Research Core will be prioritized and advertised, as well as fee structures for various categories of membership to the CHSCC. If a Core already exists, include a description of past services provided, new technologies developed, changes in protocols or Core administration, and other significant developments.

Recharge system: A recharge system (fee for service) should be developed and described. Recharge fees are allowable budgetary items in an NIH research grant. A system of payment management/accounting must be established such that it is clear to the individual users, the institutional business office, and the NIDDK what the recharge system covers and how funds recovered are being used. This will enable CHSCC investigators to appropriately adjust budgets on their individual grant and ensure accountability. This information should be transparent and applied uniformly to users in the same category of membership.

Provide a description of how each Biomedical Research Core contributes to the goals of the CHSCC. Tell how students, trainees and other early stage investigators are recruited to use the Biomedical Research Core.

In addition, provide the following information:

• Brief description of the scientific, technical, and support staff functions;
• When the Core is not being used for CHSCC activities, is it idle? Or is it being used for other institutional activities? If so, describe these other activities.
• Provide a description of how the Core will be used by at least two research projects listed in the Research Base.

Letters of Support: Include any letters of support from appropriate institutional officials or partnering institutions.

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:

• The Resource Sharing Plan in the Overall Center Overview should state that it applies to each Biomedical Research Core.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Biomedical Research Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Biomedical Research Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type PilotandFeasibility.

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

SF424 (R&R) Cover (Pilot and Feasibility Program)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Pilot and Feasibility Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot and Feasibility Program)

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

Project /Performance Site Location(s) (Pilot and Feasibility Program)

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.

Research & Related Senior/Key Person Profile (Pilot and Feasibility Program)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Pilot and Feasibility Program Director' 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.

Budget (Pilot and Feasibility Program)

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

Personnel: This category should include salary support for key personnel, including the P and F Program Director, and other professional and administrative personnel. The P and F Program Director must devote a minimum of 0.6 calendar months to the program to ensure adequate oversight. The salary amount charged to the CHSCC must be commensurate with the time spent on the P and F Program activities and is subject to institutional and NIH salary policies.

Funds may be requested to support P and F projects in areas relevant to the attaining the goals of the CHSCC.  Typically, individual P and F projects are supported with about $50,000 direct costs for each of two years, but it depends on the P and F program parameters.

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.

PHS 398 Research Plan (Pilot and Feasibility Program)

Specific Aims: Clearly state the aims of the Pilot and Feasibility Program.

Research Strategy: The P and F Program provides modest research support for a limited time (usually one or two years) to enable eligible investigators to explore the feasibility of a concept related to the mission of the CHSCC and to generate sufficient data with which to pursue it through other funding mechanisms. The P and F studies are intended to (1) provide initial support for early stage investigators; (2) allow exploration of possible innovative new leads or new directions for established investigators and (3) stimulate investigators from other areas to lend their expertise to nonmalignant hematology research. 

A clear description of the applicant pool for individual P and F projects should be made. In addition, mechanisms by which awareness of the P and F program will be communicated should be described, particularly for outreach purposes in order to increase the competitiveness of the applicant pool.

Applications for individual P and F projects will be solicited, prepared in a consistent manner, received by the CHSCC administration, reviewed by committee, funding decisions made, awards processed and oversight of research progress made. This is a significant responsibility for the CHSCC administration and must be described.

Describe how the Pilot and Feasibility program will be organized, applications solicited and selected and coordinated. Applications for a CHSCC should not describe individual projects, but rather tell how the P and F program will be administered. Support for a particular P and F project is limited to two years with an option to extend the project for an additional year, pending review of progress. It is strongly encouraged to support new investigators or investigators not currently supported as a member of the CHSCC through the P and F program. P and F projects are not intended to support or supplement ongoing research of an established investigator, unless they are embarking in a completely new area of hematology research that fits the mission of the NIDDK Hematology Program.

Letters of Support: Include any letters of support from appropriate for the Pilot and Feasibility Program by institutional officials or partnering institutions.

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:

• The Resource Sharing Plan in the Overall Center Overview should state that it applies to the Pilot and Feasibility Program.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Pilot and Feasibility Program)

When conducting clinical research, follow all instructions for completing Planned Enrollment PHS Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Pilot and Feasibility Program)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Enrichment Program.

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

SF424 (R&R) Cover (Enrichment Program)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Enrichment Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Enrichment Program)

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

Project /Performance Site Location(s) (Enrichment Program)

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.

Research & Related Senior/Key Person Profile (Enrichment Program)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Enrichment Program Director' 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.

Budget (Enrichment Program)

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

Personnel: This category should include salary support for key personnel, including the Enrichment Program Director and any other professional and administrative personnel. The Enrichment Program Director must devote a minimum of 0.6 calendar months to ensure adequate oversight of the Program. The salary amount charged to the CHSCC must be commensurate with the time spent on the Program activities and is subject to institutional and NIH salary policies.

Other expenses: Funds may be requested to support Enrichment Program activities, such as workshops, career development symposia, Center retreats, seminar series or other meetings to disseminate results from relevant research activities. Funds for Enrichment Program-associated activities, such as designing and distributing electronic flyers, printing meeting materials, as well as posters and other advertisement materials, may be requested. All efforts to reduce paper printing should be made.

Travel expenses for visiting professors/scientists may be requested.

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.

PHS 398 Research Plan (Enrichment Program)

Specific Aims: Describe the specific aims of the Enrichment Program.

Research Strategy: A CHSCC Enrichment Program should be designed to promote scientific exchange among investigators involved in NIDDK Hematology research relevant areas. It should also be designed to recruit new investigators into relevant areas of the NIDDK Hematology mission. Describe any enrichment opportunities afforded by the CHSCC participants and document ways the CHSCC may facilitate, enhance or foster the institutional training environment.

Specifically, if there is a related NIDDK T32 program, describe how the CHSCC will help to integrate, facilitate and enhance activities of T32-supported trainees. Likewise, coordinating an exchange program for students and fellows at one institution to allow short visits to another institution in order to expand their knowledge is an acceptable activity of the Enrichment Program.

While stipends for fellows cannot be funded from the CHSCC, the establishment of a CHSCC should provide an enhanced environment for research enrichment. Just as in the case of individual P and F projects, students and postdoctoral fellows need to obtain their stipend support from either Mentored Career Development awards (K01 or K08), Ruth L. Kirschstein Individual Fellowships (F30 for MD/PhD candidates, F31 to Promote Diversity in Health-Related Research or F32 for postdoctoral fellows), or regular research grants, (e.g., R01).

Letters of Support: As applicable, a letter from the PD/PI of the T32 at the CHSCC institution should be included that acknowledges and details how the PD/PI of the T32 intends to promote cohesive interactions between the two programs. Include any letters of support from appropriate institutional officials or partnering institutions.

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:

• The Resource Sharing Plan in the Overall Center Overview should state that it applies to each Enrichment Program.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Enrichment Program)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Enrichment Program)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

All PD(s)/PI(s) 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.

In order to expedite review, applicants are requested to notify the NIDDK Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the NIDDK CHSCC 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 Center 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 CHSCC that by its nature is not innovative may be essential to advance a field. The overall score for the CHSCC application may be higher or lower than the average of the individual components based on the assessment of whether the whole is greater than the sum of its parts.

• Does the CHSCC address an important problem or a critical barrier to progress in the field? If the aims of the CHSCC 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? What are the strengths of the research base (its breadth and depth) and the relevance and interrelation of the separately funded research projects to the focus/theme of the CHSCC? Is a strong, scientifically sound research base in nonmalignant hematology described? What is the likelihood that the CHSCC will increase efficiency; promote new research directions and meaningful collaborations among CHSCC investigators; facilitate interactions and collaborations among the investigators; and improve cost effectiveness? Is the CHSCC as a whole scientifically compelling?
• Are the overall goals significant and focused on a specific theme in nonmalignant hematology?

• Are the PD(s)/PI(s), collaborators, and other researchers well suited to the CHSCC? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI , do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are the PD/PIs committed to achieving the stated goals of the CHSCC?
• Are they willing to interact with each other and contribute to the overall objectives of the NIDDK Hematology Centers program? What are the scientific and administrative leadership abilities of the proposed CHSCC Director (and Associate Director, if named)? Will the PD(s)/PI(s) devote adequate time and effort to the program?
• Are the Core/Program Directors well-qualified and appropriate?
• For applications designating multiple PD(s)/PI(s), is there a reasonable plan that describes appropriate coordination, communication and conflict resolution among the PD(s)/PI(s)?

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 CHSCC? 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?

• Are there at least two Cores within the Center that feasibly can provide a reagent, resource or expertise on a national level?
• Does the CHSCC show evidence of fostering multi-disciplinary collaborations among its member investigators? (Refer to Table C.) Have such collaborations contributed to new research directions? (Refer to Table C.)
• Are there coordination and synergy of the Cores, Pilot and Feasibility program and Enrichment program towards achievement of the central scientific theme of the Center? (Refer to Table B.)
• What is the likelihood that the strategy for achieving the goals of the Center will be successful?

If the CHSCC involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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

• Does the CHSCC show evidence of a stable or growing research base with strong and consistent record of scientific excellence and achievement reflected in an outstanding level of productivity and continuing success in securing peer-reviewed research funding? (Refer to Tables A.1, A.2 and A.3.) How well does the Research Base relate to the theme of the CHSCC?

Reviewers will provide an overall impact score to reflect their assessment of each component. The overall impact scores of the components will be factored into the Overall Score for the Center application.

Administrative Core

Reviewers will provide an overall impact score to reflect their assessment of this component, using the following:

• What is the likelihood for the Administrative Core to exert a sustained and coordinating influence on the function of the Center?
• Is the administrative and organizational structure appropriate and adequate to the attainment of the objective(s) of the proposed CHSCC?
• Is the management plan for fiscal accountability and communication within the program appropriate?
• Are the plans for coordination, problem identification and resolution, and the establishment of a strong collaborative environment for the CHSCC appropriate?

Biomedical Research Core

Reviewers will provide an overall impact score to reflect their assessment of this component, using the following:

• What is the likelihood for the Biomedical Research Core to exert a sustained, powerful influence on the research field(s) involved?
• Is provision of resources and Core services for the research base critical and justified?
• Is the relationship of the Biomedical Research Core to the central focus of the overall CHSCC strong?
• Is the Biomedical Research Core providing a reagent, assay, expertise, or resource nationally to the greater nonmalignant hematology research community?
• Is the quality of the relevant facilities or services provided and criteria for prioritization and usage appropriate?
• Are the qualifications, competence and commitment of the Core Leader(s) and key personnel appropriate?
• Is the management plan well-described, including a prioritization plan for responding to the needs of the community?
• Is there adequate quality control management?
• Is there evidence that the Core functions are flexible and able to develop new technologies, assays, or reagents?
• Does the CHSCC provide strategies for generation of Program Income and evidence of sufficient institutional support?

Pilot and Feasibility Program

Reviewers will provide an overall impact score to reflect their assessment of this component, using the following:

• What is the likelihood for the Pilot and Feasibility program to exert a sustained, powerful influence on the research field(s) involved?
• What is the likelihood that the Pilot and Feasibility Program will enable innovative ideas to be pursued?
• Are outreach activities described that would encourage Early-Stage Investigators or investigators new to the field of nonmalignant hematology research to apply for support through the Pilot and Feasibility Program?

Enrichment Program

Reviewers will provide an overall impact score to reflect their assessment of this component, using the following:

• Are plans adequately described for the Enrichment Program to promote scientific exchange among investigators involved in NIDDK hematology research relevant areas?
• Are plans adequately described for the Enrichment Program to recruit new investigators into the field(s) described in the central theme of CHSCC?
• Does the Enrichment Program describe efforts to coordinate an exchange program for students and fellows at one institution to visit another institution in order to expand their knowledge?
• What is the likelihood the Enrichment Program will promote new scientific collaborations, help to advance novel hypotheses and mentor early stage investigators?

As applicable for the CHSCC 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.

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed CHSCC involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not Applicable

Not Applicable

Not Applicable

As applicable for the CHSCC proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not Applicable

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDDK in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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 National Diabetes and Digestive and Kidney Disease Advisory Board. The following will be considered in making funding decisions:

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

Areas currently supported by the NIDDK Cooperative Specialized Hematology Core Centers (U54) program via Biomedical Core facilities and therefore lowest funding priority will be given to:

• Hematopoietic Stem Cell (CD34+) Cell procurement and processing
• Intravital microscopy
• Super resolution microscopy
• Canine (large animal) modeling of hematopoiesis.

Instead, NIDDK is currently seeking CHSCCs with complementary Core facilities that may include (but are not limited to):

• CRISPR/Cas9 technology support
• Erythroid cell biology/physiology; globin gene regulation; hemoglobin synthesis
• Nonmammalian models of hematopoiesis
• Innovative xenograft recipient models
• Hematopoietic cell physiology; blood cell receptor biology, growth factors and signaling
• Myeloid/erythroid cell reagents
• Iron metabolism; pathophysiology of iron overload
• Computational biology or Bioinformatics applications to hematopoiesis

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. 

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

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

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

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

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

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

The PD(s)/PI(s) will have the primary responsibility for:

• Pursuing research objectives consistent with the research scope of the FOA and research favorably recommended by peer review;
• Conducting biomedical research and collecting the resulting data;
• Analyzing, interpreting and presenting results and plans to the Executive Steering Committee for approved activities;
• Submitting quarterly interim progress reports to the Executive Steering Committee for distribution to members of the CHSCC program and NIDDK staff.  Such reports are in addition to the required annual noncompeting continuation progress report.
• Publishing results, conclusions, and interpretation of the studies.
• The PD(s)/PI(s) will agree to: 1) accept the coordinating role of the Executive Steering Committee which includes evaluating objectives and research goals of the CHSCC program, and recommending modification, deletion or addition of projects within the CHSCC program; 2) follow any common protocols in which they participate for multicenter projects that are approved by the Executive Steering Committee; and 3) accept the cooperative nature of the group process, including the establishment, where appropriate, of smaller collaborative groups comprised of interacting subprojects and/or Cores.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• Participation in the overall coordination of the Cooperative Hematology Specialized Core Centers Program with the Executive Steering Committee. This includes efforts to improve and strengthen intra- and inter-Center cooperation amongst the components of the CHSCCs, and other funded NIDDK Hematology programs as it pertains to cross-fertilization of basic research disciplines within and between CHSCCs. As a means of improving inter-Center cooperation, the Project Scientist will directly participate in the activities of the smaller collaborative groups as established by the Executive Steering Committee. This will include activity of the Pilot and Feasibility Program, access to Biomedical Research Cores and outreach to the greater hematology research community.
• The Project Scientist will also assist the CHSCCs in achieving their missions by facilitating access to fiscal and intellectual resources provided by industry, private foundations and NIH intramural scientists.
• The Project Scientist will, as required, help reprogram biomedical research efforts, including options to modify or terminate them, by mutual consent between the CHSCC program and NIDDK. In the event of disagreements among Program participants, the Project Scientist will assist in forming an arbitration panel as discussed below.
• Interactions with each individual CHSCC awardee evaluating objectives and research goals of that particular Center, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted. The Project Scientist will assist and facilitate this process and not direct it. The Project Scientist will also provide assistance in reviewing and commenting on all major transitional changes of an individual CHSCC's activities prior to implementation to assure consistency with required goals of the Cooperative Hematology Specialized Core Centers Program.
• By retaining the option to recommend the withholding of support from a CHSCC Core or other component materially failing to meet the technical performance requirements established by this CHSCC Program. This includes identifying jointly with participants of the Executive Steering Committee the need to add additional service/reagent preparation/equipment Cores to CHSCCs or to phase out a Center service/reagent preparation/equipment Core when performance standards have not been met; and
• To participate, where warranted, in data analyses, interpretations, and the dissemination of study findings to the greater research community and health care recipients including, co-authorship of the publications arising from results generated in research conducted by the CHSCCs.

In addition, a separate NIDDK Program Official identified in the Notice of Award will be responsible for the normal stewardship and monitoring of the award including review and approval of all progress reports and all budgetary decisions. Additional responsibilities include:

• Interacting with the Program Director(s)/Principal Investigator(s) on a regular basis to monitor progress. Monitoring may include: regular communications with the PI and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at the Executive Steering Committee and related meetings.
• The NIDDK Program Official will monitor progress of the CHSCC and may request that a component be closed for reasons including: a) poor progress; b) patient safety and regulatory concerns (if applicable); c) emergence of new information that diminishes the scientific importance of that component.
• Making recommendations for continued funding based on: a) overall project progress; b) cooperation in carrying out the research and evidence of collaboration (e.g., attendance at the Executive Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality research product that has potential to fill a national need.

Areas of Joint Responsibility include:

• Participating on an Executive Steering Committee consisting of the PD(s)/PI(s) from each of the participating CHSCCs and one NIDDK staff member who will be the Project Scientist. A Chairperson of the Steering Committee, other than the NIDDK Project Scientist, will be selected by the NIDDK. Each full member of the Executive Steering Committee will have one vote. The purpose of the Executive Steering Committees will be to discuss and evaluate concerns and cooperative activities of the Cooperative Hematology Specialized Core Centers program. The Executive Steering Committee will discuss and evaluate the activity of the Pilot and Feasibility Programs, Biomedical Research Cores and the Enrichment programs. The Executive Steering Committee will establish working subcommittees as necessary and provide feedback to the subcommittee leaders at least bi-annually and implement changes in subcommittee membership or direction if needed. Awardee members of the Executive Steering Committee will be required to accept and implement policies approved by the Executive Steering Committee.
• Meetings of the Executive Steering Committee will be convened twice during the first year and annually thereafter. The annual meeting will include the External Expert Panel. These meeting are separate from any regular conference calls. The purpose of these meetings is to share scientific information, assess scientific progress, identify new opportunities and potential avenues of collaborations such as with industry, private foundations, non-CHSCC members of the research community and/or NIH intramural scientists, establish priorities that will accelerate achievement of the goals of the CHSCC, and reallocate resources. The Executive Steering Committee will document progress in written reports to the NIDDK Program Official and will provide periodic supplementary reports upon request.
• In anticipation that some CHSCCs will have common research interests that address a specific basic research problem and thus, it is envisioned that subgroups will be formed to conduct coordinated research activities as recommend by the Executive Steering Committee. As needed, the Executive Steering Committee will develop a publication policy regarding joint authorship of research reports derived from such collaborative efforts.

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 Executive 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 progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

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

Terry Rogers Bishop, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7726
Email: [email protected]

Francisco O. Calvo, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8897
Email: [email protected]

Diana Ly
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-9249
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.