Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Funding Opportunity Title

Skin Diseases Research Core Centers (P30)

Activity Code

P30 Center Core Grants

Announcement Type

Reissue of RFA-AR-11-010

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AR-14-001

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.846

Funding Opportunity Purpose

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invites applications for Research Core Centers (P30s) in skin biology and diseases. The Skin Diseases Research Core Centers (SDRCs) will provide shared facilities and services to groups of established, currently funded investigators addressing scientific problems in skin biology and diseases, in order to improve efficiency, accelerate the pace of research, and ensure greater productivity.   

Key Dates
Posted Date

January 23, 2013

Letter of Intent Due Date(s)

August 20, 2013

Application Due Date(s)

September 20, 2013

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Feb/Mar 2014

Advisory Council Review

May 2014

Earliest Start Date

July 1, 2014

Expiration Date

September 21, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives

Research in skin biology and diseases is at a stage where rapid advances frequently require access to sophisticated technologies and specialized areas of expertise that can be shared by multiple laboratories and are best provided by research core centers. Areas of skin research of interest to NIAMS that could benefit from shared core facilities include, but are not limited to:

The choice of a research area(s) upon which the Skin Diseases Research Core Center (SDRC)

would focus is made by the investigators.  However, research focused on advanced skin cancers, including metastasis and treatment, is not in the NIAMS research mission and should not be the research base for a Core Center. Any questions with regard to cancer relatedness should be directed for clarification to the Scientific/Research Contact listed in Section VII. Agency Contacts.

In addition to providing services and resources to facilitate independently funded research projects, the Core Centers are encouraged to enhance the research environment and promote synergistic collaborations among the Center Investigators (the investigators of the research base).  Scientific core personnel should help to educate the Center Investigators in the capabilities and limitations of the technologies employed by the scientific cores.  Core personnel should be involved with the investigators in designing the experiments and interpreting the results.  The technologies of the cores should not only evolve with the science conducted by the Center Investigators, but the cores should help to drive the science with increasingly sophisticated and powerful technologies. 

The SDRCs will provide support for:

Administrative Core:  An Administrative Core, including a Director, Associate Director, and an Advisory Committee, should be proposed to coordinate the Core Center activities, to evaluate and improve the Center and to administer an Enrichment Program.  The Advisory Committee should include users of the scientific cores and experts outside the Core Center Institution with expertise in the management of scientific core facilities.  This Committee should help the Director and Associate Director to regularly evaluate and optimize strategies to meet the scientific needs of the research base over the course of the grant award. 

Enrichment Program: An Enrichment Program must be proposed and should be designed to expand the research base in the area of skin biology and disease research. Within the award budget guidelines, each SDRC can decide what type of activities to include as part of the Program, based on what best suits the needs of the SDRC.  Through this Enrichment Program, the Administrative Core can utilize the Research Cores to foster the development of new investigators, new technologies, and/or new collaborations with those who have not previously participated in skin biology and disease research.  Enrichment Program activities should occur within the context and/or with the involvement of the Research Cores.  Innovative approaches to the Enrichment Programs are encouraged. 

Research Cores:  Two or more research cores must also be proposed.  A research core is a facility and/or resource shared by two or more Center investigators that enables them to conduct their independently-funded individual research projects more efficiently and/or more effectively.  Cores generally fall into one of four categories: (1) provision of a technology that lends itself to standardized procedures, automation or preparation in large batches (e.g., histology, tissue culture, high throughput sequencing, genotyping); (2) complex instrumentation (e.g., electron microscopy, flow cytometry, confocal microscopy, whole animal imaging, microarray scanning, mass spectrometry); (3) animal preparation (including transgenic and knockout) and care; and (4) methodology cores (e.g., molecular biology, cell biology, biostatistics, systems biology, bioinformatics, clinical).  Research Core support may include personnel, equipment, supplies, services, and facilities.

Core Center Directors are encouraged to leverage existing resources, such as registries, tissue banks and cohorts, and to coordinate with NIAMS-funded Core Centers at the same and/or other institutions, particularly if they provide similar or overlapping technologies and services.  Applicants from institutions that have a Clinical Translational Science Award (CTSA) funded by the NIH may wish to identify the CTSA as a resource for conducting the proposed research.  Leveraging of existing resources that provides a range of services or efficiency that would not otherwise be available is also encouraged. However, applicants should demonstrate that support for the existing resource through the Core Center provides added value to the resource beyond that which would be provided by paying for the use of the resource through a fee for service.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIAMS intends to fund an estimate of 4 awards, corresponding to a total of $1.6M Direct Costs ($2.4M Total Costs) in FY 2014. The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations.

Award Budget

Direct costs of up to $400,000 per year may be requested. This covers an Administrative Core, two or more Research Cores, and an Enrichment Program. The direct costs for the Enrichment Program must range from a minimum of $30,000 up to $100,000.   

Award Project Period

Scope of the proposed project should determine the project period.  The maximum period is five years.

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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

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

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. 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.

Letter of Intent

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

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

The letter of intent should be sent to:

Justine Buschman, M.S.
Health Science Analyst
Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Blvd., Suite 800
Bethesda, MD 20892-4872
Telephone: (301) 496-4811
Email: buschmanj@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and two identical CDs containing a color version of the application in pdf format and all appendix materials must be sent to:

Kan Ma, Ph.D.
Scientific Review Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health
One Democracy Plaza, Suite 800
6701 Democracy Blvd., MSC 4872
Bethesda, MD 20892
Phone: 301-451-4838
Email: mak2@mail.nih.gov

Page Limitations

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, with the following limitations to the Research Strategy section of each component of the application:

Relevant tables, graphs, figures, diagrams, and charts, unless explicitly excluded, are included in the page limits.

Supplemental Instruction for the Preparation of Multi-Component Applications

The following section supplements the instructions found in Form PHS 398 for preparing a multi-component grant application.

Briefly, a SDRC application consists of multiple components. First, an Overview component describes the Core Center in terms of its goals, research base, institutional environment, and recent overall progress (for renewal applications only). The Administrative Core and each Research Core component are described next.  Each component should be written as individual projects using form PHS 398. The multi-component grant application should be assembled and paginated as one complete document in the following order:

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Face Page for the Entire Application

Submit only one Face Page for the entire application.  Complete all items on the face page as directed.  In the title block, item 1, include "Core Center" as part of the title.  Mark item 2 "yes" and write in the RFA code as listed in the NIH Guide to Grants and Contracts (RFA-AR-14-002),  and "NIAMS: Core Center" for the title.

Overview

Each application should have an Overview component that serves as a synopsis of the key elements of the proposed Core Center. 

Face Page (Overview)

Do not use the NIH "Face Page"; use the PHS 398 continuation page to create a "Face Page", containing the title of "Overview". 

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (Overview)  

Describe the proposed program indicating the goals and objectives of the Core Center.  Do not exceed the space allowed. The PD/PI of the P30 and its Administrative Core is the Core Center Director.

Table of Contents (Overview)

Use the PHS 398 Continuation Format Page to write a Table of Contents appropriate for the Core Center grant application. The Table of Contents should list all components.  See Exhibit I of the Sample Exhibits for  a suggested format.  Each core should be listed by the title and Principal Investigator.  Specifically list the locations of the checklist and the various requested supporting documents, e.g., biographical sketches and supporting exhibits.

Detailed Budget for Initial Budget Period and Budget for Entire Proposed Period of Support (Overview)

Use PHS 398 form pages as directed for the composite Core Center initial year and overall 5-year budgets and do not repeat these elsewhere in the application. These composite budgets (see Exhibit V and Exhibit VI of the Sample Exhibits) summarize all individual component budgets.  Budget justifications should not be included. The overall direct cost cannot exceed $400,000 in any year.  This does not include the indirect costs of subcontracts (see NOT OD-05-004:  http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html).

To provide budget information in a format that is clear to reviewers, presentation of a consolidated budget for the initial year in a tabular form such as the sample shown as Exhibit VII in the Sample Exhibits is suggested. This table is in addition to the PHS 398 budget form pages described above.  Use the PHS 398 continuation page for the consolidated budget table.

Individual component budgets, both initial year and overall 5-year, should be included later in the application, with each core for which funding is sought. Details and justifications for all budget items must be part of the individual budgets.

The SDRC can leverage existing resources through foreign collaborations; examples include fee-for-service purchases and consultants. However, foreign consortia are not allowed.

Biographical Sketches (Overview)

Biographical sketches are required for all professional level personnel who are listed with effort in the Core Center application, including consultants.  Biographical sketches should also be included for those investigators designated as Core Center Investigators (the research base) without any dedicated effort.  The forms and instructions found in Form PHS 398 should be used.  Begin with the Center Director and place the remaining individual biosketches in alphabetical order after the budget pages.  These pages should not be duplicated in the individual Administrative Core or the Research Core components.

Resources (Overview)

Follow the instructions on the PHS 398 Resources Format Page.  In addition, please insert into this section the Table of Grants Supporting the Research Base (see Exhibit II in the Sample Exhibits) and the recommended table denoting past Use of Core Services (see Exhibit III in the Sample Exhibits, for renewal applications only). 

Research Plan (Overview)

Specific Aims: Describe the broad long-term objectives of the proposed core center.

Research Strategy: The Research Strategy section of the Overview component should describe the research base and institutional environment, the significance of the Core Center with respect to the research base, the interactions among the Center Investigators and the Cores, the innovation of the Core Center, the approach for providing core services and resources, and a progress report (renewal applications only) or any preliminary data regarding the impact of the Core Center on the research base. The Overview serves to introduce the proposed program, to state the Center objectives, and to identify the scope of research addressed in the proposed Center. This section is intended to be read by all reviewers.  Reviewers who are assigned to review one or more individual cores, but not the overall Center, are nonetheless expected to read the Overview component to provide a context for their review of the research core(s).

An additional purpose of the Overview is to provide reviewers with a sense of how the Center will impact the research base and the field of research covered by the Core Center.  A Center operates on two levels.  The first level is to provide services and scientific resources that accelerate progress on the aims of the grants in the research base.  The second level is to provide leadership at an institutional or broader level to promote quality research, foster collaborations and interdisciplinary approaches, to help to expand the ranks of investigators engaged in research on the topic of focus by the Core Center and to help drive the science of the research base with increasingly sophisticated and powerful technologies. 

The Research Strategy section of the Overview should be organized in the following fashion using the PHS 398 Continuation Format Page:

Introduction to the Overall Center

Orient the reviewer to the scientific, organizational and management structure of the Center.  Describe the goals of the Center.

Research Base and Institutional Environment

This section should provide the necessary background regarding the landscape of funded research in the topic of skin biology and diseases conducted by the research base, and the resources and service facilities currently available at the institution(s).  A strong research base is a fundamental requirement for, and a major factor in, establishing a Core Center.  Present an overview of current research in skin biology and diseases conducted at the institution(s) participating in the Core Center in sufficient detail to allow reviewers to judge its extent and the interrelationships of ongoing research. The research base should be composed of grants and investigators with well-defined connections to the theme of the Core Center. Begin with a brief summary of the projects in the research base, and continue with a descriptive narrative of how the cores can and have (for renewal applications) enhanced the projects in the research base. This narrative presentation should be organized to address the focus and interrelationships of research conducted by the Center Investigators (including the research base investigators using the cores and researchers leading and staffing the cores). Criteria for designating an investigator as a Core Center investigator should be defined in terms of the responsibilities and privileges.

To document the research base of the proposed Core Center, it is helpful to prepare a table listing the grants, their duration, the current year direct cost, and their principal investigators. Avoid an exhaustive list of grants with indistinct relationship to the Core Center. It is helpful to group the grants into aggregates of projects with similar overall goals and objectives. A suggested format is given in Exhibit II of the Sample Exhibits. The table of “Grants Supporting the Research Base” should be inserted into the Resources Format Page, Item 4.7 of PHS 398, in the Overall Resources section of the application.  Biographical sketches of the research base investigators can also be included in the application, and inserted in the Biographical Sketches section of the Overview.  Please be sure to note in the appropriate sections of the application that these materials have been provided in the Overview component.

Briefly describe the features of the institutional environment that are relevant to the effective implementation of the proposed Core Center.  A list of resources may be included in the Overview;  please elaborate on how these resources will contribute to the success of the Core Center.  As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographic distribution of space and personnel, and consultative resources.  Campus maps and floor plans of space for the cores of the Core Center are helpful, and can be inserted in the Overall Resources section of the Overview.  Include a list of who occupies specific space, the square feet and equipment in that space, and a designation of the Core Center functions associated with the spaces designated. Describe institutional commitments for space or other resources for the proposed Core Center.  Include any letters of support for the proposed Center by appropriate institutional officials. 

Significance

This section should expand on the goals of the Center and should describe the expected impact of the Core Center on the research base.  Explain the degree to which the Core Center is expected to accelerate progress on the aims of the research base grants, improve efficiency and enhance productivity.  Describe how the Center will help to expand and enhance the capabilities of the pool of investigators engaged in research related to the disease topic(s) of the Center. 

Investigators of the Research Base and Center

This section should briefly summarize the expertise and qualification of the leadership of the Center and the Research Core Directors (some duplication with the investigators sections of the Administrative Core and Research Cores is appropriate), and it should also summarize the strengths of the investigators in the research base.  Describe the record of accomplishments resulting from collaborations among the Center Investigators (research base investigators and the Core Center personnel).  Describe the balance of seniority of the Center Investigators as it relates to the potential for the Center to promote career advancement.

Innovation

Address how the Core Center will not only evolve with the science conducted by the Center Investigators, but also challenge and seek to advance or change current research or clinical practice paradigms by using novel theoretical concepts, approaches or methodologies, instrumentation, or interventions.  Explain how the synergy of the Core Center with the research base will lead to novel services and resources in the cores and their application to important questions in skin biology and diseases.  Describe the potential for interdisciplinary collaborations among Center Investigators.  For a Research Core that by its nature is not innovative, describe how it is essential to advance the field. 

Approach

Summarize the services and resources provided by the Core Center, and how they are managed and coordinated.  Describe how the Center will address the scientific needs of the research base.  Indicate if any of the proposed cores will utilize or expand cores already existing at the institution.  Describe how the proposed Core Center will leverage existing resources and fill gaps in the services available. Also describe how the Center will enhance the research base through enrichment activities.

Leveraging of existing resources is encouraged, particularly when this provides a range of services or efficiency that would not otherwise be available. Furthermore, applicants should demonstrate that support for the existing resource through the Core Center provides added value to the resource beyond that which would be provided by paying for use of the resource through a fee for service. Applicants from institutions that have a Clinical Translational Science Award (CTSA) funded by the NIH may wish to identify the CTSA as a resource for conducting the proposed research, if appropriate. 

Progress Report (if application is a Renewal Application)

All applications for renewal must provide the following information in the progress report:

It may help to utilize a table (see Exhibit III in the Sample Exhibits for example) to provide details of core facility usage.  Be sure to clarify your Center’s definition of “core user”.  This table should be inserted into the PHS 398 Resources Format Page, Item 4.7, in the Overall Resources section of the Overview.  Please be sure to note in the Progress Report section of the Overview and relevant Research Core components that you have inserted this table into the Overall Resources Section.  Please also indicate in the relevant Research Core component(s) if Progress Report Publication lists are included in the Overview component rather than in the Research Core component.

Letters of Support (Overview)

Details of the interactions of the Core Center staff with the CTSA staff and/or research personnel may be provided in a statement describing the collaborative linkages being developed. A letter of agreement from the CTSA Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) should be included here if collaborative linkages are being developed between the Core Center and the local CTSA.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide.

Administrative Core

The Administrative Core manages the overall Core Center as well as the Enrichment Program. This component should be written as an individual project using form PHS 398 without page 1 (Face Page). Instructions listed below are only for those sections with information different from the PHS 398 Application Guide.

Face Page (Administrative Core)

Do not use the NIH "Face Page"; use the PHS 398 continuation page to create a "Face Page", containing the title of "Administrative Core". 

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (Administrative Core)

Personnel: The PD/PI of the P30 and its Administrative Core is the Core Center Director. An Associate Director should also be included. List administrators and staff for the Administrative Core (not individual research cores). If Research Core Directors also help administer the overall Core Center, list them as well.  Do not duplicate Biosketches, which should be included in the Overview component.

Detailed Budget for Initial Budget Period and Budget for Entire Proposed Period of Support (Administrative Core)

Include only the budget for the Administrative Core for the initial year and for the 5-year budget plans, with justifications, and do not repeat these elsewhere in the application. The budget of the Administrative Core may include appropriate salary for the Director, Associate Director and support personnel, expenses related to the Advisory Committee (travel, teleconferences, etc.) and expenses associated with the enrichment activities. Administrative support personnel may be budgeted at no more than one full time equivalent (FTE), which may be divided among one or more positions. This FTE must be fully justified.

The Core Center must allocate a minimum of $30,000 and up to $100,000 direct costs each year to the Enrichment Program, which will be administered through the Administrative Core.  Each Core Center can decide how much money and what type of activities to include as part of the Enrichment Program, based on what best suits the needs of the Center.  All Enrichment Programs must include a detailed budget and justification. 

Research Plan (Administrative Core)

Specific Aims:  Describe the broad long-term objectives to be accomplished by the Administrative Core.

Research Strategy: Applicants are encouraged to organize the Research Strategy section of the Administrative Core to align with the centers’ review criteria for the Administrative Core.  Please include the following headings:

Leadership

Personnel of the Administrative Core should include the Center Director, who is responsible for the organization and operation of the Center, and an Associate Director, who will be involved in the administrative and scientific aspects of the Center, and will serve as Acting Center Director in the absence of the Director. 

This section should describe in detail the expertise and qualifications of the Director and Associate Director.  Their collective expertise should reflect the research breadth included in the research base of the Center.  Indicate the level of time commitment by the Director and Associate Director devoted specifically to the Center.  Define the responsibilities of the Director and Associate Director, Advisory Committee, Research Core Directors, institution officials and other involved parties. 

The Administrative Core will also manage interactions with the Advisory Committee.  Describe the plans for nominating and selecting members of this committee.  Describe the expected composition of the Advisory Committee (number of members, types of expertise, etc.), but do NOT name the members of the committee (those outside the Core Center Institution) in the application so as not to limit the pool of potential reviewers.  The Advisory Committee should include both users of the cores and investigators external to the Core Center who may have expertise in the design and management of other core facilities or expertise in the technologies and services offered by the cores. 

Management and Evaluation

The Administrative Core is responsible for coordinating and integrating the Core Center components and activities.  Describe the management plans for the Core Center, including fiscal administration, procurement, property and personnel management, planning, budgeting, etc.  If the Core Center will involve more than one institution, it may be necessary to explain how the management plans will coordinate activities at these sites.

If the demand for the services or resources provided through the Core Center exceeds the supply or if a queue is likely to develop, describe criteria for establishing priorities or other strategies for managing supply or demand. 

Core Centers are encouraged to conduct ongoing evaluation of use of the cores, the quality of the services and resources provided, and the efficiency by which they are delivered.  The Center should also monitor current and predict future scientific needs of the research base, and Research Core activities should adapt to those needs.  The Advisory Committee should be actively involved in this evaluation and planning process.  Describe the plans for the Director, Associate Director and Research Core Directors to meet regularly with this committee.  Indicate the format of the meetings; describe any reports on Center activities that will be provided to the committee members and how the committee may convey comments and recommendations back to the Center leadership.  Describe how the recommendations from this committee will be integrated into the planning and management of the Center over the course of the award.

Communication

Describe the plans for maintaining effective communication within the Core Center and the plans for communication with the investigators of the research base and other potential users of the cores.  This plan should take into consideration the geographic distribution of Center investigators.  Explain how the communication plans will help to coordinate and integrate the investigators and the activities of the Center. 

Enrichment Program

An Enrichment Program, designed to expand the research base in the area of focus of the Core Center and administered through the Administrative Core, must be proposed.  The applicant must justify how the activities of this Program will aid in bringing new investigators (either early-stage or from a different field) into the research field of the Center.  Through this Enrichment Program, the Administrative Core can utilize the Research Cores to foster the development of new investigators, new technologies, and/or new collaborations with those who have not previously participated in the research field of the Center.  Types of activities that may be part of an Enrichment Program include (and are not limited to) mentoring programs and activities, pilot and feasibility studies (mentored or non-mentored), and support of seminars and visiting scientists.  Enrichment Program activities should occur within the context and/or with the involvement of the Research Cores.  Innovative approaches to Program Enrichment are encouraged.  All Enrichment Programs must include a detailed description of Program leadership and management. 

If the Center chooses to include direct funding for research (e.g., through a Pilot and Feasibility program and/or mentored activity), descriptions of such projects or individuals named for support should NOT be included in the application.  However, plans for soliciting, reviewing, selecting, managing and reporting on the results of projects during the tenure of the Core Center, and/or plans to select mentees and projects should be included in the application.  A Pilot and Feasibility program should not be used to fund clinical trials.

Human Subjects and/or Vertebrate Animals: If a Center elects to support a Pilot and Feasibility project program, describe the internal institutional plans and procedures to ensure that all projects supported from this award will comply fully with all applicable Federal regulations, policies, and Guidelines, including those for research involving human subjects, including the evaluation of risks and protections in project proposals and appropriate ethical oversight of funded projects.  Human Subject and Animal Subject approval dates for Pilot and Feasibility projects (if applicable) should NOT be submitted with the application, but should be provided to NIAMS for approval with Just in Time information, or prior to the start of the pilot project, and with annual progress reports.  Otherwise please indicate in the appropriate section that human subjects or vertebrate animals are not involved.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide.

Research Cores

Two or more research cores must be proposed.

A Research Core in a Core Center is a shared facility and/or resource that provides a service(s) that enables Core Center investigators to conduct their independently-funded individual research projects more efficiently and/or more effectively.  Cores should be designed to furnish a group of investigators some service, technique, assay, or instrumentation in a manner that will enhance the research in progress, utilize human resources more effectively, and improve the quality and cost effectiveness over investigators conducting the studies without the core.  A core should also attract new investigators to an area of research by offering specialized services not easily duplicated in an individual laboratory.

Cores may be proposed in relation to any acceptable research activity of the Core Center, but usually fall into one of four categories:  (1) provision of a technology that lends itself to standardized procedures, automation or preparation in large batches (e.g., histology, tissue culture, high throughput sequencing, genotyping); (2) complex instrumentation (e.g., electron microscopy, flow cytometry, confocal microscopy, whole animal imaging, microarray scanning, mass spectrometry); (3) animal preparation (including transgenic and knockout) and care; and (4) methodology cores (e.g., molecular biology, cell biology, biostatistics, systems biology, bioinformatics, clinical data such as a patient database).

In addition to providing a product or a service, a core must maintain appropriate quality control.  Training in complex techniques and methodologies for Core Center investigators is also an important function of these cores.  The cores are not intended to supplant investigator capabilities, but rather are intended to enhance their opportunities to learn and become proficient in the core technologies.

Limited research may also be an appropriate function of a core facility so long as it is directly related to enhancing the functioning or utility of the core and is not an undertaking that could be funded through other mechanisms.

Present each research core separately as an individual project using the regular PHS 398 forms without page 1. The Research Plan should contain all the standard sections. Instructions listed below are only for those sections with information different from the PHS 398 Application Guide.

Face Page (Research Cores)

Do not use the NIH "Face Page"; use the PHS 398 continuation page to create a "Face Page", containing a descriptive title of the Core (e.g., “Core 1: XXX”, “Core B: XXX”, etc.).

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (Research Cores)

Personnel: A director should be named for each core.  Core directors may be acknowledged experts with an independently-funded research program that will use the core services. In such cases, the percent effort on the grant is usually relatively low. Alternatively, a core director may be a more junior scientist with reasonable expertise who may devote a greater effort to the core.   List only administrators and staff for the Research Core. Do not duplicate Biosketches, which already are provided in the Biographical Sketches section of the Overview component.

Detailed Budget for Initial Budget Period and Budget for Entire Proposed Period of Support (Research Cores)

Use budget form pages as directed for the initial year and 5-year budgets with justifications, and do not repeat these elsewhere in the application. It is important to provide comprehensive budgetary justifications, and to discuss mechanisms for reimbursing core services.

This grant mechanism is not intended for acquisition of high-cost equipment.  Equipment purchases by any Research Core in excess of $25,000 for any year of the grant would require special justification.  Under unusual circumstances, where costly items of equipment are requested, the application must document available equipment within the institution and provide clear justification in terms of core service to be provided by the Core Center investigators.  Costly items of equipment should be funded through other sources.

Resources (Research Cores)

Special attention should be given to describing the space and resources available for the core service(s) proposed. A table denoting Use of Core Services (see Exhibit III in the Sample Exhibits) may be helpful to describe for reviewers the projected use of the proposed core by funded investigators.

The description of the physical arrangements and instrumentation for the cores should be given special attention.  Institutional commitment to provide space or to cost share in equipment should be documented if possible.  In renewal applications, any changes should be carefully documented.  Whenever possible, Core Centers are encouraged to enter into cooperative arrangements with established cores in other centers or resource grants offering a similar type of service at the applicant institution.

Research Plan (Research Cores)

Specific Aims:  Describe the broad, long-term objectives, and describe concisely the specific aims to be accomplished by the core.  Include research to enhance the capabilities of the core, or training activities, if proposed.

Research Strategy:  Describe the background information and gaps that led to the proposal of the core.  What value will be added to the research base by support through the Core Center, beyond that which could be accomplished by a similar level of funding used to purchase services from another source?  This is an especially important point to document if the proposal is to buy into an existing institutional core. The establishment of Research Cores within a Core Center may be justified only on the basis of use by independently funded Core Center investigators.  The NIAMS encourages the establishment of cores that provide cost effective resources essential for the research of multiple investigators, and at a minimum, each Research Core should be utilized by at least two investigators.  How the core will enhance the research productivity of these investigators should be described.

The organization and proposed mode of operation of each core should be presented.  Included should be a plan to prioritize investigator use of the core as well as a definition of qualified users.  Choose this definition carefully, since a goal of the Center should be to expand the ranks of investigators engaged in research on skin biology and diseases and to promote interdisciplinary research, while including investigators distantly related to the field may cause the resources of the core to be spread too thinly.  If the core is used to train investigators in special techniques, the extent of, and approach to this training should be included.

It is expected that center investigators using the core will provide some reimbursement to the core.  This reimbursement plan will offset some of the core costs specific for a project using the core.  The reimbursement plan should be described. 

Each proposed technique or service should be described in enough detail to allow the reviewers a comprehensive evaluation.  Where applicable, include sections on quality control and data analysis.  See Exhibit IV in the Sample Exhibits as an example for the kind of information that would be helpful to the reviewers. 

For renewal applications, recent progress report on the research core may be included here, but this should not duplicate the content included in the overall progress report included in the Overview component.  Please indicate if the Progress Report Publication Lists are included in the Overview component rather than in the Research Core component.  Please also note if a table of use of the core facility has been included in the Overall Resources section of the Overview component. 

Human Subjects and/or Vertebrate Animals: NIH has policies for human subjects (including inclusion of women, minorities and children) and animal subjects which must be addressed in each Core.  For each Core, for both Humans and Animals, state explicitly whether 1) the Core itself involves human or animal activity or 2) that no work is done in the Core that goes beyond approved protocols of other projects in the research base, or 3) that there is no human or animal activity involved. 

If the Core itself involves human or animal activity the required human and animal sections must be completed. No additional human or animal information is required for other projects within the research base.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide with the following modifications:

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the NIAMS, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

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.

After the review of the individual components of the application, an overall impact/priority score will be assigned to the application. This score will reflect not only the quality of the individual Research Cores and Administrative Core, but also how the proposed SDRC will bring together all these elements in an effective and cohesive unit. The overall score may be higher or lower than the “average” of the components based on the assessment of whether the “whole is greater than the sum of its parts.”   

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the SDRD 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 SDRD proposed).

Scored Review Criteria - Overall

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 research core that by its nature is not innovative may be essential to advance a field.

Significance

Does the SDRC address an important problem or a critical barrier to progress in the field? If the aims of the SDRC 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 is the scientific quality of the individual Research Cores and Administrative Core?  Will the proposed cores enhance the research base in the field of skin biology and diseases?  Does the set of proposed Research Cores collectively provide the most appropriate services and resources to meet the scientific needs of the research base?    

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the SDRC? 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? Do the SDRC Director and Associate Director have the leadership and research qualifications to lead a Center? Does the leadership team (Director, Associate Director, and Advisory Committee) have the collective expertise to assure focused development and implementation of high-quality and meaningful basic and clinical research projects? 

Innovation

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?  Will the services and resources provided by the SDRC not only evolve with the science conducted by the Center Investigators, but are they also likely to drive the science with increasingly sophisticated and powerful technologies?  Is the SDRC likely to promote interdisciplinary research? For a research core that by its nature is not innovative, is it essential to advance the field? 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the SDRC? 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 effective Leadership, Management and Evaluation, and Communication plans?  Is the Enrichment Program designed to effectively expand the research base in the area of skin biology and disease research? Is it likely that there will be coordination, collaboration and synergy among the individual Research Core components, Administrative Core component and existing research base? Are the services and resources of the Research Cores of high quality? Does support for the service or resource through the Core Center provide added value beyond that which would be provided through a fee for service, especially where support is proposed for an existing resource? Are the Research Cores cost-effective in providing services and resources to the Center Investigators?  Do the Research Cores effectively leverage existing resources at this or another institution?

If the SDRC involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?   

Environment

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 application define a productive, high quality and adequately funded (with federal and private peer-reviewed funding awards) research base that needs the services and resources proposed by the Center?  Are the Center Investigators well defined in terms of their relationship to the Core Center, and are their letters of support for the application adequate to suggest that the cores will be fully utilized?  Is the research base sufficiently broad to foster new research and to promote interdisciplinary collaborations?  Does the proposed Core Center utilize available resources well?  Where support by the Core Center for existing institutional scientific resources is proposed, does that resource provide a range of services or efficiency that would not otherwise be available to members of the Center? If there will be a connection with an NIH funded CTSA, is the collaboration well described and is there an adequate letter of agreement from the CTSA Program Director(s)/Principal Investigator(s)? 

Review Criteria for the Administrative Core:

Reviewers will consider the following criteria in the determination of an overall impact score for the Administrative Core, although scores for the individual criterion will not be provided.

Leadership.  Do the SDRC Director and Associate Director have the leadership and research qualifications to maximize the success of the Center?  Have the Director and Associate Director proposed adequate time commitment to effectively manage the Center?  Are appropriate and well- defined responsibilities described for the Director and Associate Director, Advisory Committee, Research Core Directors, institution officials and other involved parties?  Are there adequate plans for establishing the Advisory Committee, and for the Director and Associate Director to communicate regularly with the committee?  Are the composition and plans for selecting the members of the committee appropriate? 

Management and Evaluation.  Is the management plan appropriate for fiscal administration, procurement, property and personnel management, planning, budgeting, etc; are the Core Center budgets appropriate for the proposed work to be done in core facilities, for an Enrichment Program, and for any other proposed programs in relation to the total Core Center?  Are there adequate plans for objectively evaluating the functioning of the Core Center by the Director and Associate Director, with input from the Advisory Committee?  How will the recommendations of the Committee be integrated into the effective fiscal, personnel and scientific management of the Core Center over the course of the grant award?

Communication.  Are there adequate plans for the establishment and maintenance of effective internal communication and cooperation among the Core Center investigators, core personnel, leadership of the Center, and the Advisory Committee? If the Core Center will involve multiple sites or institutions, is there a detailed plan of the communication strategies aimed to integrate the distant components and investigators into a coordinated Center?  Will communication through the Enrichment Program reach all of the Center Investigators as well as investigators beyond the Center in order to promote expansion of the pool of users of the Core facilities for the study of skin biology and diseases?

Enrichment Program.  Is there a well-designed and innovative plan for activities that are likely to enhance the communication, coordination and collaboration among Center Investigators and to expand the pool of investigators and broaden the spectrum of research in skin biology and diseases conducted through the Center?  If the proposed Enrichment Program includes a Pilot and Feasibility program, are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects?

Review Criteria for Research Cores:

Reviewers will consider the following criteria in the determination of an overall impact score for the Research Cores, although scores for the individual criterion will not be provided.

Significance.  Does the Research Core provide services and/or resources to meet the scientific needs of the research base?  Will the Core be used by multiple investigators?  What is the likelihood that the Research Core will increase efficiency, accelerate progress and promote new research directions and meaningful collaborations among Core Center investigators?

Investigators.  Are the qualifications, experience, and commitment of the Research Core Director and his/her collaborations with Core Center investigators appropriate to the proposed technical area?

Innovation.  Will the services and resources provided by the Research Core not only evolve with the science conducted by the Center Investigators, but are they also likely to drive the science with increasingly sophisticated and powerful technologies?  Is the Research Core likely to promote interdisciplinary research?

Approach.  Are the services and resources of the Research Core of high quality? Does support for the service or resource through the Core Center provide added value beyond that which would be provided through a fee for service, especially where support is proposed for an existing resource? Are there procedures for quality control of the services and resources for each core?  Is the Research Core cost-effective in providing services and resources to the Center Investigators?  Do the Research Cores effectively leverage existing resources at this or another institution?

Environment.  What is the overall quality of the environment for the Research Core?  Does it include the institutional commitment to the program, including lines of accountability regarding management of the Research Core, and to individuals responsible for conducting essential Core Center functions?

Additional Review Criteria - Overall and Cores

As applicable for the SDRC and Cores 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.   

Protections for Human Subjects

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed SDRC and Cores involve clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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.

Biohazards

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.

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period. Have the benefits of the Core Center been documented in the forms of enhanced scientific productivity, increased collaboration, success in achieving funding for new research directions, and cost savings? .

Revisions

Not Applicable

Additional Review Considerations - Overall and Cores

As applicable for the SDRC and Cores 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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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).

Resource Sharing Plans

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIAMS, 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:

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 and 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 Arthritis and Musculoskeletal and Skin Diseases Advisory Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information

1. Award Notices

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement. If Pilot and Feasibility projects are included in the Centers program,  a complete project application (including biographical sketches, personnel and budget justification, research plan, human and/or animal subject sections and any IACUC, IRB or other required documentation), and the critiques of the proposals by the Advisory Committee must be provided to NIAMS with the Just in Time information or prior to the start of the Pilot and Feasibility projects. 

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. 

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Carl C. Baker, M.D, Ph.D.
Program Director, Keratinocyte Biology and Diseases
Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health
6701 Democracy Blvd., Suite 800
Bethesda, MD 20892-4872
Phone: (301) 594-5017
Email: bakerc@mail.nih.gov

Peer Review Contact(s)

Kan Ma, Ph.D.
Scientific Review Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health
One Democracy Plaza, Suite 800
6701 Democracy Blvd., MSC 4872
Bethesda, MD 20892
Phone: (301) 451-4838
Email: mak2@mail.nih.gov

Financial/Grants Management Contact(s)

Stephanie Kreider
Grants Management Specialist
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health
6701 Democracy Boulevard Suite 800
Bethesda, MD 20892
Phone: (301) 594-3535
Email: skreider@mail.nih.gov  

Section VIII. Other Information

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.

Authority and Regulations

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 Parts 74 and 92.


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