Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Minority Health and Health Disparities (NIMHD) National Center for Research Resources (NCRR) (No Longer participating per NOT-OD-12-078)
Funding Opportunity Title	Research Centers in Minority Institutions Program (G12)
Activity Code	G12 Research Centers in Minority Institutions Award
Announcement Type	New
Related Notices	December 09, 2016 - This PAR has been reissued as RFA-MD-17-003. June 24, 2013 - See Notice NOT-MD-13-005. Notice to Extend the Expiration Date. March 19, 2012 - See Notice NOT-OD-12-078. Notice of Change in Participation of NIH Institutes and Centers.
Funding Opportunity Announcement (FOA) Number	PAR-11-132
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.307
FOA Purpose	The purpose of the Research Centers in Minority Institutions (RCMI) Program is to expand the national capability for research in the health sciences by providing grant support to minority institutions that offer doctorate degrees in the health professions or in a health-related science. These institutions historically have trained professionals from diverse backgrounds who provide health care to minority populations and are uniquely positioned to engage these populations in research and in the translation of research advances into culturally appropriate, measurable and sustained improvements in health outcomes. The primary goals of the RCMI G12 Centers are to (1) develop research infrastructure to enhance institutional biomedical research capacity; (2) enable investigators to become more successful in obtaining competitive extramural support for the conduct of biomedical and/or behavioral research, particularly on diseases that disproportionately impact minority populations; and (3) foster environments conducive to professional development in the biomedical sciences.

Posted Date	February 25, 2011
Letter of Intent Due Date	April 25, August 25, December 25
Application Due Date(s)	Standard dates apply
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date(s)	Standard dates apply
Expiration Date	(Extended to September 30, 2013 per NOT-MD-13-005), Originally September 8, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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.

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

The NIH recognizes a unique and compelling need to promote diversity in biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; improve the quality of the educational and training environment; balance and broaden the perspective in setting research priorities; improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and improve the Nation's capacity to address and eliminate health disparities. The National Center for Research Resources (NCRR) provides laboratory scientists and clinical researchers with the environments, tools and training they need to understand, detect, treat and prevent a wide range of diseases with the goal of building capacity to bring effective prevention and treatment strategies more quickly into practice. NCRR programs accelerate and enhance research along the entire continuum of biomedical science.

Minority institutions historically have trained professionals who provide health care to minority populations and are uniquely positioned to engage minority populations in research and in the translation of research advances into culturally competent, measurable and sustained improvements in health outcomes. The Research Centers in Minority Institutions (RCMI) program was established by NIH in 1985 as a result of congressional interest in the development of a program to expand the national capability for research in the health sciences. Through the development of research infrastructure in minority institutions, their potential to contribute to research advances that are necessary to eliminate disparities in health and disease experienced by members of minority communities is greatly enhanced.

This FOA provides competitive grant support for an RCMI G12 center in those minority institutions which offer doctoral degrees in the health professions or the sciences related to health. The primary goals of an RCMI G12 center are to: (1) develop and enhance the institutional research infrastructure necessary for the conduct of biomedical and/or behavioral research; (2) enable minority institutions to become more successful in obtaining competitive extramural support for the conduct of biomedical and/or behavioral research; and (3) enhance the biomedical research environment at these institutions.

The nature and scope of an RCMI G12 center may vary widely in different institutional settings. However, the center must be focused on developing a specific area(s) of research, rather than being broad-based and directed toward many different scientific themes. Each applicant must assess and plan a program to address its own research needs and vision. The applicant must describe and justify how existing and requested resources will be utilized and leveraged to implement the institutional plan to develop, expand, and maintain an environment and framework suitable for achieving the objectives of their RCMI program. Moreover, plans for enhancement of biomedical research capacity must be consistent with the long-range goals of the applicant institution and must include an evaluation plan to determine the extent to which program goals are achieved. RCMI G12 centers must provide infrastructure to:

• study the underlying causes of diseases, including those diseases that disproportionately affect minority populations in the U.S.
• support basic research that will lead to approaches for the diagnosis, prevention, and/or treatment of diseases to improve health or address health disparities especially in minority populations
• foster collaborations among disciplines, departments, and/or schools of an institution; and collaborations with other institutions
• facilitate professional development activities in biomedical and/or behavioral science

The RCMI program is designed to allow flexibility in the types of research resources required to accomplish RCMI program goals at the applicant institution. The most important criterion for inclusion of any component in the proposed G12 Center is the extent to which the activity or resource will enable the institution to achieve the stated goals. At least two-thirds of the requested funds are expected to be directed to multi-user resources, rather than to support individual research projects. The RCMI program is not intended to duplicate or supplant funding from the wide array of programs currently available for support of specific investigator-initiated research projects.

Key Activities of an RCMI G12 Center

The RCMI G12 center must support biomedical research and the needs of its researchers. The center must include infrastructure and/or activities that will support:

• Program administration
• Sharing of resources, expertise, data and technologies
• Collaborations between researchers within the institution and collaborations and partnerships with investigators at other institutions, foundations or industry
• Professional development activities for investigators
• Evaluation of each key activity of the RCMI program as well as the overall RCMI program

In addition to these requirements, applicants also must develop their own list of key activities to achieve the specific objectives of the RCMI G12 center. Potential key activities may include but are not limited to those listed below.

• Recruitment and hiring of additional faculty investigators/research staff
• Biomedical informatics resources
• Research design, biostatistics, and research ethics
• Technologies and resources for core laboratories
• Alterations and renovations of laboratories and animal facilities
• Pilot project program

Descriptions of Required G12 Center Key Activities

1. Administrative Core

The Administrative Core will be directed by the Principal Investigator(s) of the RCMI G12 center and must provide the logistical support for the RCMI program. The Administrative Core must develop activities to facilitate the professional development of the research faculty and post-doctoral fellows.

2. Collaborations and Partnerships

All applicants must develop plans in the required area of collaborations and partnerships. A key component of the RCMI program is fostering collaborations between researchers from different disciplines, departments and/or programs within the institution, as well as collaborations with investigators at other institutions. Applicants may propose activities that will facilitate intra-institutional and multi- or interdisciplinary collaborations if they do not currently exist at the applicant institution. In addition, research partnerships with other academic organizations are strongly encouraged. If an institution has other NIH-supported programs, the applicant must demonstrate how the proposed G12 award interfaces with these awards. Applicants must also indicate how they will utilize the RCMI Translational Research Network (RTRN) consortium and other consortia and resources to facilitate collaborations with investigators at other institutions. Applicants may include associated budget allocations to use the resources of the RTRN as appropriate.

Each applicant is strongly encouraged to identify one or more collaborating domestic institution(s), which may include Federal or non-Federal, public or private, and for profit or non-profit organizations. Applicants are encouraged to partner with foundations, industry, and community organizations as appropriate. In such cases, these partners must agree to follow NIH policies with respect to (1) listing of clinical trials at www.ClinicalTrials.gov; (2) sharing of resources; (3) data sharing and public access, including placing publications in PubMedCentral; and (4) establishing policies in support of investigator academic independence, reporting of patents or patentable concepts, and publication rights.

3. Professional Development Activities

The RCMI G12 center must provide professional development activities for post-doctoral fellows and junior investigators and enhance synergy with professional development activities associated with the Clinical Research Education and Career Development (CRECD) R25 awards and/or other NIH-funded research training and career development programs currently at the institution. Resources may be requested to support seminars, workshops, mentors and/or other professional development activities that promote the recruitment, advancement, and retention of investigators in biomedical research careers.

4. Evaluation

Applicants must provide a detailed formative and summative evaluation plan. This evaluation must include milestones for each key activity; milestones for the overall program in terms of enhancement of the institutional infrastructure and environment necessary to facilitate biomedical research in the areas identified by the applicant, increased productivity of investigators, and success in applying for and obtaining extramural research funding; and detailed quantitative and/or concrete criteria by which milestone achievement will be assessed.

Descriptions of Potential Key Activities

1. Recruitment and Hiring of Additional Faculty Investigators/Research Staff

This may include hiring of investigators who have track records of independent research support that includes current or recent support (within the last two years) by NIH R-series, P-series, and/or U-series awards, or other federal or non-federal awards and can serve as mentors to junior investigators. These new faculty may receive up to $100,000 per year for up to three years to augment institutional support to establish their research laboratories, acquire specialized equipment, and support postdoctoral fellows and technical assistants. In addition, postdoctoral fellows may be recruited and/or research associates and technical staff hired.

2. Research Design, Biostatistics, and Research Ethics

Applicants may request resources to assist investigators with developing design and analysis plans for studies. Applicants may also propose to develop innovative research programs that bridge research in study design, biostatistics, and research ethics with other national activities, including those of the RTRN, Clinical and Translational Science Award (CTSA), or other consortia. Topics for research might include, for example, preventing bias, improving recruitment and retention, developing innovative methods of enhancing the statistical power of studies, gathering of appropriate data, developing design and analysis plans for studies of unique or vulnerable populations and sub-populations, or new methods for addressing disparities in specific populations.

3. Biomedical Informatics Resources

If biomedical informatics resources are requested, applicants should consider both internal, intra-institution and external interoperability to allow for communication among RCMI awardees through the RCMI Translational Research Network (RTRN) and with other research partners (e.g., universities, government, clinical research networks, and pharmaceutical companies). Applicants should utilize the biomedical informatics support services provided by the RTRN when conducting multi-site studies and leverage resources provided through CTSAs, the Biomedical Informatics Research Network (BIRN), and other NCRR- and NIH-funded resources.

4. Technologies and Resources for Core Laboratories

If core research resources are requested, they must be for multiple users, including infrastructure applicable to various disciplines in the institution (e.g., medicine, nursing, dentistry, pharmacy, public health, biostatistics, epidemiology, and/or bioengineering) for the benefit of researchers and research projects across research areas. Standard operating procedures are required as is participation in national or international quality control and standardization efforts where appropriate. Proposed resources should be fully justified within the context of the overall program goals, and not duplicate locally available resources. The level of support requested must be justified by the projected use by biomedical researchers from within the applicant institutions. Laboratory equipment, supplies, and personnel are all acceptable costs. Cost recovery for core support should be sought from funded investigators.

5. Alterations and Renovations of Laboratories and Animal Facilities

Alteration and renovation (A&R) costs to improve existing research/core laboratories or animal facilities are allowed. This FOA will provide up to $500,000 in direct costs for A&R only in year one of the award as a one-time cost expenditure. Although this amount will be provided only in year one, the proposed A&R work does not have to be completed in Year 1. All A&R work must be completed before expiration of the project period. Alteration and Renovation projects must be relevant to the scope of the proposed research. Sufficient detail must be provided to estimate the cost and suitability of the project. Funds designated for A&R under this FOA cannot support new construction, including completion of shell space, or the purchase of movable research equipment/instrumentation or equipment intended for teaching or other non-research related purposes. A list of allowable equipment is available at http://ncrr.nih.gov/research_funding/instruments/. Please note that A&R costs will be approved only for facilities improvements at the applicant organization. Proposed improvements at consortia sites are disallowed.

6. Pilot Project Program

An applicant may request support for a pilot project program that 1) allows biomedical researchers to generate preliminary data for submission of grant applications, particularly those that focus on research related to diseases that disproportionately impact minority populations, or that address health disparities; or 2) develops new technologies that will better position the institution to conduct biomedical research. Such funds must be readily available and be accompanied by an organizational structure that supports full compliance with regulatory requirements.

Administration of RCMI G12 Centers

NCRR will accept applications that name Multiple Principal Investigators: http://grants.nih.gov/grants/multi_pi/ as key personnel on applications. Applications designating multiple PD/PIs should include a section of the research plan, entitled Multiple PD/PI Leadership Plan (Section I of the Research Plan in the PHS 398). A rationale for choosing a multiple PD/PI approach should be described. The PD/PIs may be assisted by a Program Director(s) who must also be an experienced investigator(s) who has administrative skills and backgrounds that complement those of the PD/PIs. The amount of effort for the PD/PIs and Program Director(s) must be commensurate with the requirements of the position and not less than 20% each and sum to not less than 50%. This level of effort is required whether or not salary is requested. If budget allocation is proposed, the distribution of resources to specific components of the project or the individual PD/PIs must be delineated in the Leadership Plan. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

The Directors of the Key Activities of the center must be experienced investigators who possess the stature, knowledge, authority, leadership, and administrative skills and capabilities necessary to direct the resource, and to speak for the RCMI institution in national forums. Applicants should include the costs associated with attendance at the annual PD/PIs meeting in the administrative budget.

Funding Instrument	Grant
Application Types Allowed	New Renewal Revision Resubmission The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	For new applications, direct costs are limited to $1,500,000 per year, excluding one-time expenditures for equipment and/or costs for alterations and renovations. This FOA will provide up to a total of $500,000 for equipment in year 1 or year 2 for new applications only. Alteration and renovation (A&R) costs to improve existing research/core laboratories are limited to $500,000 for A&R only in year 1 of the project period.
Award Project Period	The scope of the proposed project should determine the project period. The maximum period is 5 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.

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

Nonprofits Other Than Institutions of Higher Education

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

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are notallowed.

To be eligible for this FOA, applicant institutions must demonstrate that they serve a high concentration of individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in biomedical research (African Americans, American Indians and Alaska Natives, Native Hawaiians and other Pacific Islanders, Hispanic Americans). Applicant institutions must be minority institutions in the United States and its territories which award doctorate degrees in the health professions or the sciences related to health, and must demonstrate that the majority of the health professional graduates provide health related care to minority communities.

Applicant organizations must complete the following registrations as described in the PHS398 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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) 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 four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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 PHS398 Application Guide.

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

Applicant organizations may submit only one application.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

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

It is critical that applicants follow the instructions in the PHS398 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:

• Descriptive title of the proposed research
• Name, address, and telephone number of the PD/PIs
• Names of other key personnel
• Participating Institutions
• Number and title of this funding opportunity

The letter of intent should b sent to:

Shelia A. McClure, Ph.D
Division of Research Infrastructure
National Center for Research Resources
6701 Democracy Blvd. Room 924
Bethesda, MD 20892
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 451-6536
Email: mcclursh@mail.nih.gov

Pre-Application Meeting: The NCRR anticipates holding a technical assistance meeting in April 2011, through a viodeoconference to which all interested prospective applicants are invited. For details, check the NCRR website at www.ncrr.nih.gov.

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 must be sent to:

Steve Birken, Ph.D.
Office of Review
National Center for Research Resources
6701 Democracy Blvd. Room 1078
Bethesda, MD 20892-4874
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: 301-435-0815
Email: mcclursh@mail.nih.gov

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed and order of assembly, with the following exceptions or additional requirements:

Detailed Budget for the Initial Budget Period; Budget for the Entire Proposed Period of Support

The budget section should begin with the summary or composite budget for the center, followed by the individual budgets for all key activities and consortia and contractual arrangements. Do not separate the individual Key Activity budgets into each Key Activity section.

Biographical Sketch

All Biographical Sketches should be grouped together with the PD/PIsbiographical sketch(es) presented first followed by all other sketches in alphabetical order. Do not separate the biographical sketches into each key activity section.

Research Strategy

RCMI Program Overview (30 pages, total)

This section includes the following: a) significance of the program and how the proposed program will address an important problem or critical barrier for biomedical research at the institution, b) institutional setting and commitment, including a description of the current research environment, c) approach, d) governance of the proposed center, and e) a progress report for renewal/revision applications.

Administrative core (12 pages, total)

Administrative components include such entities as the administrative office, grants office, and other offices that provide the logistical support for the Center. The Administrative Core also includes a description of the oversight committees for the Center such as the Internal and External Advisory Committees.

Collaborations and Partnerships (6 pages, maximum, per activity)

The RCMI G12 Centers participate in activities to facilitate intra-institutional collaborations and in consortium-based activities aimed at developing collaborative projects across centers. In cases where an institution has other RCMI awards and/or other NIH-funded research capacity-building programs, RCMI G12 Centers have collaboration and synergy between these program activities.

Professional Development Activities (6 pages, maximum, per activity)

Each RCMI G12 Center has Professional Development Activities (e.g., seminars, workshops, short courses, mentorship programs, or other professional development activities) available to all researchers.

Evaluation Plan (12 pages, total)

Each RCMI G12 Center must have an evaluation plan conducted by an external evaluator. For the overall program and each proposed key activity, the plan includes the objectives of the evaluation or tracking activities, the principal measures or indicators, and potential data sources.

Potential Key Activities/Cores:

Recruitment and Hiring of Faculty Investigators/Research Staff (12 pages , total)

Applicants may include components for recruiting and hiring additional faculty investigators and/or research staff required to accomplish the goals of the RCMI 12 Center.

Biomedical Informatics Resources (12 pages, total)

Applicants may include specific biomedical informatics resources needed by the Centers including staffing of the resource.

Technologies and Resources for Core Laboratories (12 pages maximum, per core)

Cores provide assay services (e.g., genetic testing, immunology, proteomics); multi-user equipment; and expert consultations.

Pilot Project Program (12 pages, total)

A pilot Project program solicits applications from investigators and funds collaborative projects.

Alterations and Renovations (12 pages, total)

Each RCMI is permitted to request up to $500,000 total costs, in year 1 for minor alterations and renovations. These requests are described and justified in this section.

Tables. Tables can be distributed throughout the application. Tables should be associated with their respective sections and should appear at the end of that section. Tables will count against the page limits in the Research Strategy sections. The organization and content of the tables are left up to the applicant, but tables must contain information on:

• Current NIH-funded faculty development activities and training programs, and other centers within the institution that are available to biomedical researchers
• The biomedical research investigators in the proposed center including their scientific expertise
• Collaborators and partners, project titles and scientific expertise of collaborators, and other relevant information in support of the collaboration/partnership
• The number of publications and manuscripts accepted for publication
• Grants submitted by investigators that are specifically attributable to RCMI funding and/or use of RCMI-funded resources, and the grants funded (including funding source)
• Other scientific and program accomplishments in progress reports for renewal and revision applications

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Description of Special Programmatic Requirements of the Research Strategy Sections

Section 1. Program Overview (30 pages, total)

Section 1.1. Significance, Institutional Setting and Commitment

The application must include a description of the institution and clear detailed evidence of institutional commitment to the RCMI Program. Applicants must:

• state the goals of the proposed RCMI program and how the proposed program will address an important problem or critical barrier for biomedical research at the institution
• provide a brief history of the institution and its mission of training and/or serving underrepresented minority populations and how this program will help to address the lack of underrepresented minorities in biomedical research
• provide an analysis of organizational, educational, and scientific strengths and weaknesses
• provide specific institutional commitments that will be made to support the achievement of RCMI program goals.

Applicants must provide the following information (using a table format):

• current funding for biomedical research
• resources in the current research environment such as those for biomedical informatics; research design and biostatistics; research ethics; existing core laboratories; and other resources and facilities that support biomedical research
• current faculty development activities; training programs; other centers; and other activities and services within the institution that are available to biomedical researchers
• the biomedical research investigators in the proposed program including their scientific expertise.

Section 1. 2. Overall Approach

Applicants must describe the plan to develop, expand, and maintain an environment and framework suitable for achieving the objectives of the proposed RCMI program; and describe and justify how existing and requested resources will be utilized to implement the institutional plan. Applicants must use this section of the application to describe the following components and functions:

• key activities of the proposed program and how they will be coordinated to achieve each of the institutional goals for the RCMI program
• the scientific and/or administrative expertise of faculty and staff who will participate in the RCMI program
• how existing institutional and other core resources and activities (i.e. in biomedical informatics, biostatistics, research design and ethics, core laboratories and technologies, and other activities and resources), existing collaborations/partnerships, and funding will be leveraged to achieve the objectives of the proposed RCMI program
• innovation of the proposed RCMI program
• plans for maintaining an innovative and integrated program resulting in an RCMI program that fosters an environment conducive to conducting biomedical and/or behavioral research and research training, and increasing the research competitiveness.

The applicant must describe the process by which the RCMI program will be implemented and integrated into the strategic plan of the institution. Applicants must provide detailed performance milestones and a timeline that will be used to measure progress in each budget period toward the goals of each activity. This section must include:

• a clear description of interim objectives to be achieved for each activity during the course of the project
• potential impediments that could require a revision of the milestones with a discussion of possible solutions
• detailed quantitative and/or concrete criteria by which milestone achievement will be assessed
• detailed schedules or timelines for the anticipated attainment of each milestone in each RCMI component and overall RCMI goals with alternatives should milestones not be reached (e.g., GANTT Charts)

Section 1.3. Governance

Applicants must describe:

• the structure and governance of the RCMI, including availability of faculty and other staff
• procedures for allocation of physical space available for research faculty
• accountability for the structure, function, and budget of the program
• the process of selecting, evaluating and, if necessary, replacing the directors of individual program activities
• how appropriate institutional credit will be awarded to activity directors
• how the PD/PI(s) will identify and address under-utilization, low productivity, and other problems, including failure to achieve milestones
• the continuing evaluation of the quality, productivity, and equitable access and utilization of resources

As appropriate the application must also include the Multiple PD/PI Leadership Plan. The leadership plan must describe:

• rationale for choosing a multiple PD/PI approach
• governance and organizational structure of the leadership team
• communication plans and process for making decisions on scientific direction
• procedures for resolving conflicts
• roles and administrative, technical, and scientific responsibilities for the program

Section 1.4 . Progress Reports for Renewal and Revision Applications

The Progress Report must be part of the Program Overview, and will count against the 30 page limit defined for this section. Renewal/revision applications must provide a progress report that describes what has been accomplished in the current award cycle. List the specific RCMI goals for the prior funding period and emphasize progress in terms of these goals. Identify accomplishments in the following four categories: institutional development, improvements in the research environment, faculty development and achievement, and research productivity. Accomplishments that are reported must be specifically attributable to RCMI funding and/or RCMI-funded resources. Summarize the extent, nature, and utilization of RCMI resources; provide scientific highlights from research projects using the resources; and a progress report for pilot projects must be included if projects were funded during the current project period. List problems encountered and describe how these problems have or will be addressed. A table listing grants submitted and grants funded (including funding source); the number of publications and manuscripts accepted for publication; patents; and other materials that demonstrate accomplishments should be included in this section. Publications and manuscripts accepted for publication attributable to RCMI funding and/or use of an RCMI-funded resource should be listed in the Bibliography and References Cited section 5.5.5. b of the PHS 398 form.

Section 2. Required Key Activities

Section 2.1. Administrative Core (12 pages, total)

The Administrative Core must be directed by the PD/PI(s) of the center and must provide the logistical support for the center. Salary support may be provided for an administrative assistant and other administrative support personnel if justified. The Administrative Core must provide services, activities, and/or programs to meet the research needs of the faculty and post-doctoral fellows. Support may be provided for attending national scientific meetings and workshops to interact with the scientific leaders in the field. Additionally, scientific workshops and visiting faculty programs may be organized as a part of the Administrative Core's scope of activities.

An Internal Advisory Committee (IAC) must be established prior to submission of the application. Depending on the scope and complexity of the RCMI program, the IAC may consist of six to eight members. Meetings of the IAC should be held at least quarterly. The RCMI must also have an External Advisory Committee (EAC) that meets at least annually to review structure and progress and offers recommendations to the RCMI PI. Potential members of the EAC should not be named in the application, but their roles and the type of expertise of the members should be described. Depending on the scope and complexity of the RCMI program, the EAC may consist of eight to ten members. The efforts and recommendations of the IAC and EAC should be coordinated. Plans for documenting IAC and EAC recommendations must be described as well as plans for following-up on recommendations. The Administrative Core should coordinate meetings of the IAC, EAC and other meeting related to the center.

Section 2.2. Collaborations and Partnerships (6 pages maximum, per activity)

A required component of this initiative is collaboration between researchers from different disciplines, departments, or units within an institution, and collaborations with investigators in other institutions. In addition, applicants are strongly encouraged to form partnerships with other academic and non-academic organizations. The collaborating organizations or institutions must be domestic and may include Federal or non-Federal, public or private, and for profit or non-profit organizations.

Applicants must describe how the RCMI environment facilitates intra-institutional collaborations. In cases where an institution has other RCMI awards and/or other NIH-funded research capacity-building programs, RCMI grantees must demonstrate that there are collaboration and synergy between these program activities. Applicants must describe the academic qualifications, research experience, and productivity of collaborators from other institutions and describe their contributions to the success of the RCMI.

Applicants must describe their participation in the RCMI Translational Research Network (RTRN) consortium and how they will utilize the RTRN to facilitate collaborations and enhance research in the proposed RCMI center, especially research focused on those diseases that disproportionately impact minority populations. Applicants must describe how its researchers collaborate, share, and disseminate resource tools and resources at institutional and national levels. Plans must be included to describe how regulatory requirements that impact collaborations will be addressed. Applicants must indicate the institution's willingness to participate in the RTRN, CTSA, and other consortia focused on the development, adoption, and implementation of best practices in conducting biomedical research and research training. Collaborators and partners, their funding, project titles, and other relevant information in support of the collaboration/partnership must be provided.

If partnering institutions/organizations are proposed, there should be a thorough description of the partnership as well as the administrative and fiscal relationships that have been established between the RCMI and the collaborating institution(s)/ organizations.

Section 2.3. Professional Development Activities (6 pages maximum, per activity)

Applicants must provide detail on the activities proposed (e.g., courses, mentorship program, seminars, workshops or other professional development activities). In addition, the applicants must describe the plans for the administration of the proposed activities, and provide a description of the qualifications and role of the individual(s) providing leadership, and administrative management and coordination of the proposed activities.

Applicants must provide evidence of how RCMI biomedical research professional development activities support the institutional training/career development programs. For example, if the institution currently has a Clinical Research Education and Career Development (CRECD) in Minority Institutions award, applicants must describe this program and indicate how the proposed professional development activities enhance the CRECD program.

Section 2.4. Evaluation (12 pages, total)

The application must include a detailed evaluation plan conducted by an external evaluator, to assess implementation of the short-term and long-term RCMI program goals, implementation of specific program activities, and document the accomplishments anticipated for each budget period and within the total award period. This evaluation must include milestones for the overall program in terms of enhancement of the institutional infrastructure and environment necessary to facilitate biomedical research in the areas identified by the applicant, increased productivity of investigators, and success in applying for and obtaining extramural research funding. For the overall program and each proposed key activity, the plan should include the objectives of the evaluation or tracking activities, the principal measures or indicators, and potential data sources.

Listed below are examples of evaluation objectives for illustrative key activities:

Biomedical Informatics

• Assess the demand for the resource
• Assess informatics performance
• Identify effective practices of intra- and inter-organizational sharing of data

Design, Biostatistics and Research Ethics

• Assess the demand for the resource
• Assess support for study design and analysis and the tools and methods supplied
• Assess the effectiveness of research topics prioritization
• Assess the effectiveness of education in topics such as research ethics

Core Resources

• Track availability and use of resources
• Assess needs of research community and integration with other resources
• Assess studies to meet standards for quality of science
• Address under-utilization and poor performance

Overall Operational Functions

• Assess budget implementation, allocation of resources, and leveraging of additional resources to achieve program objectives
• Assess effectiveness of resource sharing
• Assess software dissemination plan

Section 3. Examples of Potential Key Activities

Section 3.1. Recruitment and Hiring of Additional Faculty Investigators (12 pages, total)

Applicants should describe plans for recruiting and hiring additional faculty investigators that may be required to accomplish the goals of RCMI. This may include hiring of senior magnet investigators who must have independent research support and can serve as mentors to more junior investigators. These new faculty may receive support to establish their research laboratories, acquire specialized equipment, and support postdoctoral fellows and technical assistants. If junior faculty members are hired, the application must contain a general plan for professional development. The plan should include policies on protected time for research and other activities and policies that will support the professional development of junior investigators.

Section 3.2. Biomedical Informatics (12 pages, total)

Applicants should describe:

• Director of the resource and staffing
• the resources that will be offered, with plans for operations and management, prioritization, and tracking
• the user pool for the requested resource that includes a description of the research projects, collaborators, and funding sources
• plans to establish communication with relevant external organizations
• the process by which standards and other mechanisms will be developed and used to maximize interoperability between internal systems and systems in external organizations
• proposed interactions with the RCMI Translational Research Network (RTRN)
• assessment of informatics performance with external partners {e.g., RTRN, Clinical and Translational Science Award (CTSA)}
• plan for inter- and intra-organizational sharing of data, technology, and best practices

Section 3.3. Research Design, Biostatistics, and Research Ethics (12 pages, total)

Applicants should describe:

• Director of the resource and staffing
• support that will be provided for study design and analysis
• resources that will be available to develop tools or methods in these areas
• plans for operations and management, prioritization of research topics and projects, and tracking
• educational topics that will be available to instruct investigators
• how research ethics will be integrated into services
• proposed interactions with the Research Design and Biostatistics components of RTRN

Section 3.4. Technologies and Resources for Core Laboratories (12 pages maximum, per core)

Applicants should describe:

• Director of the resource and staffing
• the resources that will be offered, with plans for prioritization, availability, management, and tracking
• the user pool for the requested resource that includes a description of the research project, collaborators, and funding sources
• the integration of resources with similar resources at the institution and any affiliates
• how the institution will anticipate and be responsive to changing needs of the biomedical research communities
• evaluation of studies to justify an investigator’s continued access to resources
• plans for cost recovery from funded investigators, where appropriate.

Section 3.5. Alterations and Renovations (12 pages, total)

Applicants must relate the proposed renovations to the research projects that will use the facility. If renovations to animal facilities are proposed, the proposed renovations must be related to the projected animal population by species, and include the lines of authority and responsibility for administering the institution's animal care and use program. The role and composition of the Institutional Animal Care and Use Committee (IACUC) and how compliance with relevant laws, policies, and guidelines are achieved must also be included.

Applicants must list the functional components, including the size (dimensions) and square footage of each component (room, alcove, cubicle) that will be directly affected by the renovation project. Engineering criteria applicable to each component (mechanical, electrical, and utilities) must be included such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam. Applicants must also list appropriate architectural criteria (such as width of corridors and doors, surface finishes). All fixed equipment items requested for the renovated area must be listed and justified.

Line Drawings and Cost Estimates

Submit line drawings on 8 1/2" x 11" paper only. (Do not submit blueprints) These drawings will not be counted against the 12-page limit. All floor plans must be legible, with the scale clearly indicated.

The line drawings of the proposed renovation must be at a scale adequate to explain the project. The drawings must indicate size (dimensions), function, and net and gross square feet of space for each room. The total net and gross square feet of space to be renovated must also be given. The plan must indicate the location of the proposed renovation area in the building. Include the as-built drawings of the proposed renovation area and indicate any areas that will be demolished. Any changes or additions to existing mechanical and electrical systems must be clearly described in notes made directly on the plan or attached to the plan. Indicate the type(s) of new finishes to be applied to room surfaces. Detailed cost estimates must be included. Provide vendor quotes when available.

Section 3.6. Pilot Project Program (12 pages, total)

Applicants should describe the plan to solicit applications, prioritize the projects and to review their methodology and research performance. The description of the Pilot Project program should include the scope; eligibility requirements; the limit on the dollars available and the number of years of support per project; the solicitation, submission, review, and selection criteria and process; oversight and evaluation procedures; and assurances that all projects supported from this grant will comply fully with all applicable Federal policies, rules, and guidelines for research involving human subjects. Applicants must describe the support and resources in place to ensure all research designs are sound and that statistical analyses are appropriate and rigorous. Applicants should not propose individual research projects in the application.

If a pilot project program is proposed that includes junior investigators, a general plan addressing their transition to independent investigator status must be included. This plan should describe mentoring activities and describe how the institution intends to facilitate the transition from the research support of pilot projects to competitive grant support through applications submitted by its faculty members to relevant NIH Institutes and Centers or to other appropriate Federal or non-Federal agencies or organizations. Junior investigators conducting pilot projects must have at least one mentor. Applicants must describe how mentors for junior investigators will be selected; provide a description of mentoring activities during the planning, execution, and after completion of the pilot studies; and describe how the mentoring activities will be evaluated. In some instances a suitable mentor may not be available within the applicant's institution and it is therefore acceptable to enlist appropriate mentors from outside institutions. Mentors may receive up to 1.8 person months of salary support.

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 PHS398 Application Guide.

Appendix

An appendix is not allowed.

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 PHS398 Application Guide.

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

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 postmarked on or before the due dates in Part I. Overview Information.

Upon receipt, applications will be evaluated for completeness by the Office of Review, NCRR. Applications that are incomplete will not be reviewed.

For renewal applications, the direct costs of any given year cannot exceed the direct costs of the final year of the non-competing application by more than 5%.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the PHS398 Application Guide.

Additional supplementary material will not be accepted after the receipt of the application.

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/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Are plans for the enhancement of the biomedical research capacity consistent with the long-range goals of the applicant institution? Do the applicants propose to develop infrastructure to study the underlying causes of diseases, including those diseases that disproportionately affect minority populations in the U.S.? Will the proposed activities enhance basic research that will lead to approaches for the diagnosis, prevention, and/or treatment of diseases to improve health? Will the proposed program significantly advance the overall quality of biomedical and/or behavioral research and the research environment at the applicant institution? Will the proposed program have potential to enhance the research competitiveness of the investigators at the institution?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? 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? Will the PD/PIs have sufficient authority and credibility in the institution to work across institutional boundaries? Will the PD/PIs have the environment and institutional support necessary to be responsible for the resources committed by the institution(s) for the RCMI?

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? Are new approaches proposed that would integrate basic and pre-clinical, clinical and/or other relevant (e.g., public health, bioinformatics, social and behavioral sciences) disciplines in research? Is the program likely to develop novel approaches to increasing the ease and efficiency of biomedical and/or behavioral research at the grantee institution?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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?

If the project 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? Does the applicant describe and justify how existing and requested resources will be utilized to implement the institutional plan to develop, expand and maintain an environment and framework suitable for achieving the objectives of the proposed RCMI program? Does the RCMI program foster collaboration among disciplines, departments and/or schools of an institution, and collaboration with investigators across institutions? Does the program describe activities that will enhance the professional development of investigators? Does the application identify key obstacles to the performance of biomedical research and then propose plans or means to overcome these? Will the proposed RCMI include relevant scientific disciplines and collaborations to maximize productivity? Will the various components and key activities of the proposed program be coordinated into one effort within the center? Is an implementation phase well described? Is the timeline for implementation feasible and are specific goals and milestones set? Are alternatives proposed should the goals and milestones not be reached in a timely manner?

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? Are there plans to coordinate RCMI activities across relevant disciplines, departments, and schools in the applicant institution? Does the program demonstrate synergy with other NIH-funded activities at the institution? Does the application make efficient use of potentially unique resources, such as access to research networks and/or clinical resources? Will the RCMI program enhance, complement, and extend the applicant's current resources for biomedical and/or behavioral research?Does the application provide strong evidence that the RCMI will provide resources that would not otherwise be possible?

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Institutional Commitment: Is there institutional commitment to establishing the RCMI program as an integral part of its overall biomedical and/or behavioral research environment? Is there substantial commitment from the institutional leadership to protect the time of the investigators to pursue biomedical research? Is the institutional leadership committed to this program and its goals in terms of providing specific assets for the program, such as financial support, faculty support, specific equipment, dedicated space, or tuition rebates, as a few examples? Will existing NIH-supported cores be appropriately shared with the RCMI program?

Governance: Have the applicants described an effective administration and governance structure that will promote biomedical and/or behavioral research? Is the governance structure designed to ensure both accountability and integration of the components of the RCMI into a coherent program? Are the PD/PIs qualifications and experience appropriate to provide effective leadership in implementing the institutional RCMI plan and to support institutional commitment to biomedical research? Is the plan for developing and managing key activities including collaborative and consultative arrangements adequate? Will the leadership and governance plans accommodate changes in the direction of research and allow for the efficient use of funds? Will External and Internal Advisory Committees be constituted to provide critical, stimulating, and thoughtful advice for the overall RCMI performance and RCMI Activities? Is there a process to resolve conflicts and a plan to implement recommendations?

Administrative Core: Does the Administrative Core provide appropriate logistical support for the RCMI program? Does the Administrative Core include services, activities, and/or programs to meet the administrative needs of the research faculty and post-doctoral fellows? Does the Administrative Core coordinate the activities of the Internal and External Advisory Committees?

Collaborations and Partnerships: Does the center facilitate intra-institutional collaboration? Has the applicant included collaborations with investigators from different disciplines, departments, and/or programs within the institution, as well as investigators from other institutions? Do the investigators from other collaborating institution(s) have the appropriate academic qualifications, research experience, and productivity to make contributions to the success of the RCMI program? If an institution has other RCMI-supported programs, does the applicant demonstrate how the G12 award interfaces with these programs? Has the applicant described their participation in the RCMI Translational Research Network (RTRN) and how they plan to utilize the RTRN to facilitate collaborations and enhance research of the proposed RCMI center? Are there a commitment to and plans for participating in the development, adoption, and implementation of best practices through the RCMI Translational Research Network (RTRN) and other national consortia where appropriate?

Professional Development Activities: Is the approach feasible and appropriate to achieve the stated professional development goals? Is there evidence of appropriate collaboration among programs and departments to integrate professional development activities across the institution? If the applicant institution currently has funding for a Clinical Research Education and Career Development (CRECD) in Minority Institutions award, how do the professional development activities enhance this program? Is there evidence that the educational program of the CRECD will benefit the RCMI G12 Center?

Evaluation: Does the application include the required detailed evaluation plan conducted by an external evaluator? Is there an evaluation plan that includes key milestones for the overall program and for each proposed key activity? Is the plan adequate to evaluate the short-term and long-term goals for each of the proposed key activities? Do the milestones and timelines provide feasible objectives, and detailed quantitative and/or concrete criteria by which milestone achievement will be assessed? Are the measures valid for the program’s goals to be assessed and how accessible and practical are the available data sources?

Review Criteria for Potential Key Activities

Recruitment and Hiring of Additional Faculty Investigators/Staff: If recruitment and hiring of additional faculty and/or staff are requested, are they appropriately justified? Will the new faculty/staff improve the capability of the institution to conduct biomedical and/or behavioral research? Is there adequate potential for new junior investigators to achieve scientific independence under the mentorship of senior investigators within or affiliated with the RCMI program? Has the applicant provided a timetable with appropriate expected hire dates for new faculty/staff?

Biomedical Informatics: If resources for biomedical informatics are proposed, does the applicant describe existing resources for biomedical informatics and will these new resources overlap existing informatics infrastructure? Will the biomedical informatics resources offered be commensurate with the breadth of the RCMI program? Will the Biomedical Informatics support services provided by the RCMI Translational Research Network (RTRN) be utilized for multi-site studies? Will data security and privacy be safeguarded? Will the institution work toward interoperability of the informatics systems and participate in the development of national data standards through the RCMI Translational Research Network? Will the Biomedical Informatics Director have the necessary authority to ensure the implementation of best practices? As applicable, will this resource be sufficient for intra- and inter-institutional operations?

Research Design, Biostatistics, and Research Ethics: What types of support and resources will be in place to ensure all research designs are sound and that statistical analyses are appropriate and rigorous? If new resources are proposed, is there overlap with the existing and proposed resources? Does the applicant describe plans for investigators to consult with experts in research design and biostatistics before experiments are undertaken? Will training include conflict of interest, federal codes requirements, guaranteeing privacy and safety of research participants, especially as pertaining to vulnerable populations? As applicable, will this resource be sufficient for intra- and inter-institutional operations? Will the Research Design and Biostatistics components of the RCMI Translational Research Network (RTRN) be utilized in multi-site studies?

Technologies and Resources for Core Laboratories: If core research resources are requested, are they for multiple users, including infrastructure applicable to various disciplines in the institution (e.g., medicine, nursing, dentistry, pharmacy, public health, biostatistics, epidemiology, and/or bioengineering) for the benefit of researchers and research projects across research areas? Are the rationale and need for the resource to achieve institutional RCMI program goals adequate? Is there overlap with existing resources? Is the importance of the facility to the research of the faculty sufficiently addressed? Will resource utilization and evaluation be adequate? Is there flexibility in types of resources to be offered? Is there sufficient information on the number of projects or protocols that utilize core resources, including the demonstrated need for current or requested equipment? Are the adequacy and appropriateness of administrative and scientific leadership for implementing and managing the resource(s), including collaborative and consultative arrangements sufficiently described? Are the qualifications of the director of the core facility adequate? Is the plan for the resource, including objectives, implementation strategy and timetable, SOP for use and management of the facility; and involvement of the IAC and EAC sufficiently described? Are the plans to institutionalize support for this resource or components of the resource over time reasonable?

Alterations and Renovations: Are requested alteration and renovation projects relevant to the scope of the research activities of the faculty? If renovations to animal facilities are proposed, do the proposed renovations relate to the projected animal population by species? If renovations to animal facilities are proposed, are the lines of authority and responsibility for administering the institution's animal care and use program indicated? Are the role and composition of the Institutional Animal Care and Use Committee (IACUC) and how compliance with relevant laws, policies, and guidelines are achieved described? Are there lists of the functional components, including the size (dimensions) and square footage of each component (room, alcove, cubicle) that will be directly affected by the renovation project? Are there appropriate descriptions of the engineering criteria applicable to each component (mechanical, electrical, and utilities) including information such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam, as well as the appropriate architectural criteria (such as width of corridors and doors, surface finishes)? Is justification provided for all fixed equipment items requested for the renovated area? Are legible line drawings provided for all floor plans with the scale clearly indicated? Are the line drawings of the proposed renovation drawn to a scale adequate to explain the project? Do the drawings indicate size (dimensions), function, and net and gross square feet of space for each room? Are the total net and gross square feet of space to be renovated provided? Does the plan indicate the location of the proposed renovation area in the building? Does the plan include the as-built drawings of the proposed renovation area and indicate any areas that will be demolished? Do the plans indicate changes or additions to existing mechanical and electrical systems in notes made directly on the plan or attached to the plan? Do the plans indicate the type(s) of new finishes to be applied to room surfaces?

Pilot Project Program: If a pilot project program is proposed, is there an adequate plan to solicit applications, to prioritize the projects and to review their methodology and research performance? Will the expected benefits to the RCMI be measured and tracked? Will lessons learned be shared? Do the applicants describe the support and resources in place to ensure that all pilot project research designs are sound and that statistical analyses are appropriate and rigorous? If the program includes junior investigators, is there a general plan for mentoring and facilitating transition from the research support for pilot projects to competitive grant support from relevant Federal or non-Federal agencies? Are there plans to assign mentors for junior investigators that are qualified in terms of having external support and an independent research laboratory?

Key Activities that are not listed above will be reviewed using the standard review criteria.

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 project involves 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

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

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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

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

As part of the scientific peer review, all applications:

• Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Research Resources Councill. The following will be considered in making funding decisions:

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

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

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

Not Applicable.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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.

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
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

Shelia A. McClure, Ph.D
Division of Research Infrastructure
National Center for Research Resources
6701 Democracy Blvd. Room 924
Bethesda, MD 20892
Telephone: (301) 451-6536
Email: mcclursh@mail.nih.gov

Steven Birken, Ph.D.
Office of Review
National Center for Research Resources
6701 Democracy Blvd., Room 1078
Bethesda, MD 20892-4874
Phone: 301-435-0815
Fax: 301-480-3660
E-mail: birkens@mail.nih.gov

Quadira Huff
Office of Grants Management
National Center for Research Resources
6701 Democracy Blvd., Room 1062
Bethesda, MD 20892-4874
Telephone: (301) 435-0852
FAX: (301) 480-3777
Email: huffq@mail.nih.gov

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.