Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Funding Opportunity Title	Nutrition Obesity Research Centers (P30)
Activity Code	P30 Center Core Grants
Announcement Type	Reissue of RFA-DK-10-003
Related Notices	January 26, 2012 - This RFA has been reissued as RFA-DK-12-004.
Funding Opportunity Announcement (FOA) Number	RFA-DK-11-012
Companion FOA	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)	93.847
FOA Purpose	This FOA issued by the National Institutes of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, invites grant applications from institutions/organizations that propose to establish core centers that are part of an integrated program of nutrition and/or obesity-research. The Nutrition Obesity Research Center program is based on the core concept, whereby shared resources aimed at fostering productivity, synergy, and new research ideas among the funded investigators are supported in a cost-effective manner. Each proposed NORC must be organized around central themes that reflect the nutrition and/or obesity research focus of the center members.

Posted Date	July 1, 2011
Letter of Intent Due Date	October 19, 2011
Application Due Date(s)	November 16, 2011
AIDS Application Due Date(s)	Not Applicable.
Scientific Merit Review	February-March, 2012
Advisory Council Review	May 2012
Earliest Start Date(s)	July 2012
Expiration Date	November 17, 2011
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.

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 objective of the Nutrition Obesity Research Centers program is to bring together basic science and clinical investigators from relevant disciplines to enhance and extend the effectiveness of research related to nutritional sciences and/or obesity, and related disorders, with clinical and/or translational applications in these areas. The NIDDK-supported Nutrition and Obesity Research Centers (NORC) are part of an integrated program of nutritional sciences and obesity research. The NORC program combines the previously supported NIDDK Clinical Nutrition Research Units (CNRUs) and the Obesity Nutrition Research Centers (ONRCs) into one centers program.

INSTITUTION AND RESEARCH BASE

A Center must be an identifiable unit within a university or medical center or a consortium of cooperating institutions, including an affiliated university. An existing program of excellence in biomedical basic and clinical research in the areas of nutritional sciences and/or obesity, and related disorders, is required. The research must be in the form of research project grants (R01), program project grants (P01), Resource-Related Research Project Grant (R24), or other peer-reviewed research that is already funded by NIH, other Federal Agencies, or non-federal groups at the time of submission of the Center grant application. It is required that at least fifty percent of the nutritional sciences and obesity or other related disorders research comprising the research base be supported by Federal Agencies. Close cooperation, communication, and collaboration among all involved personnel of various professional disciplines are ultimate objectives.

ADMINISTRATIVE CORE

NORC applications must include an administrative core that will be responsible for allocation and oversight of Center resources. The Administrative core will also be responsible for planning an enrichment program and for implementing a process for solicitation, review and selection of projects for the Pilot and Feasibility Program within the Center. In addition, all Nutrition Obesity Research Centers will be required to maintain a Center website, with the administrative core taking primary responsibility for its creation and oversight, as well as for ensuring proper and seamless integration of the Center website with the NIDDK Center program website.

The NORC Director, who is the Program Director/Principal Investigator (PD/PI) on the P30 application and Director of the Administrative Core, must be a scientist who can provide effective administrative and scientific leadership and who has demonstrate proficiency in managing a large, multi-component project. The Director will be responsible for the organization and operation of the NORC and for communication with the NIDDK on scientific and operational matters. Center Directors are required, and their administrators are strongly encouraged, to attend Center Director's meetings to be held at a location to be determined by the NIDDK. Funds for travel to this meeting should be included in the budget of the Administrative Core of the Center. The Core Center Director should provide at least 1.2 person months (calendar year) effort on the Administrative Core and a total of 2.4 person months (calendar year) effort distributed among the Administrative and other components of the Center. One or more Associate Directors should be named who will be involved in the administrative, scientific, or training efforts of the Center and who will serve as Acting Center Director in the absence of the Director. A process must be in place that would be used to recommend a successor to the Director, if needed. An administrative assistant may also be proposed.

RESEARCH CORES

The NORCs are based on the core concept. Four to six cores are usually included in a Center. Cores are defined as shared resources that enhance productivity or in other ways benefit a group of investigators working in nutritional sciences and/or obesity and related disorders research to accomplish the stated goals of the Center. Examples of such resources include biostatistics, imaging, biotechnology, and instrumentation facilities. It is appropriate and may be beneficial to have one or more central themes around which core center research investigations are focused.

Centers are encouraged to foster clinical and/or translational research. This clinical component can exist in multiple formats, as a stand-alone core, a 'clinical component' as part of the administrative core, a combination of the two, or some other format that supports clinical research. Besides leading to a better understanding of disease etiology and natural history of disease, such cores might provide biostatistics support; enhance clinical study design; enhance collaboration among researchers and recruitment of subjects for clinical studies; provide for epidemiological studies; or provide modest funding for tissue, DNA, or serum storage. In addition, a clinical or epidemiology core may more effectively address NIH policies concerning issues of children, women, and ethnic minority participation in clinical studies.

In responding to this FOA, applicants are encouraged to propose cores that address specific objectives based on the unique requirements of investigators at the applicant institutions. Particular emphasis should be placed on services that support and foster interdisciplinary, integrated and translational approaches to research in Nutrition Obesity Research Center topic areas. Preference will be given to core support services that are not readily available or cost-effective when supplied from commercial sources, and techniques or technologies that may be technically challenging or require specialized expertise, equipment or infrastructure.

Proposed NORC research cores may be an institutional shared research core. In such cases, the research core support provided by the NORC should be proportional to the use of the institutional research core by NORC members. As with other research cores, details about access and prioritization of center members to the shared research core(s) should be provided. Moreover, the applicant should document that the NORC will be in a position to have some input to, and oversight of, the shared institutional core with respect to its management, planning for future changes and improvements, etc.

The need for core support from the NORC must be well-justified, with clear documentation of a broad user base of NIDDK-funded investigators pursuing research activities in Center topic areas, as well as nutrition and/or obesity researchers with other sources of peer-reviewed support. Participants in the NORC program are encouraged to become fully integrated into, and synergistic with, other NIDDK- and NIH-funded Core Centers within their institutional setting. This includes the clinical research homes being established by the Clinical and Translational Science Awards supported by the National Institutes of Health (http://www.ctsaweb.org/) and other NIH Common Fund activities, and any related NIDDK-funded Center programs: http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/. Applicants should provide information on other programs supporting related resources at their institution and describe the nature of synergy and integration between the NORC and these other activities. Applicants must also clearly describe how duplication or redundancies of effort, services and resources will be avoided.

Two other types of activities should also be supported with Center funding: a pilot and feasibility (P/F) program and an enrichment program.

PILOT AND FEASIBILITY PROGRAM

The P/F program provides modest support for new initiatives or feasibility research studies. This program is directed at new investigators, at investigators established in other research disciplines with expertise that may be applied to obesity or nutritional sciences research, and at established investigators who wish to make a substantial change in the direction of their nutritional sciences or obesity-related research. It is expected that the majority of P/F project investigators will fall into the first category and only in exceptional circumstances will investigators in the third category be supported. In addition, temporary salary support for one Named New Investigator in a specified area of research with a defined P/F study may be requested for up to 24 months, with subsequent individuals to be named by the Center Director and approved by the Center's External Advisory Board and the NIDDK.

ENRICHMENT PROGRAM

The Core Center grant may include limited funds for program enrichment such as seminars, visiting scientists, consultants, and workshops. The NORC enrichment program should be designed to advance translational research in nutrition and obesity and promote scientific exchange among investigators with research interests in these topic areas, and to enhance interactions between nutrition and obesity researchers and investigators from other fields with relevant expertise. The enrichment program can support activities such as seminars, guest speakers, visiting scientists, consultants, and workshops.

Applicants should describe any training opportunities afforded by the NORC for Center participants, and document ways the Center may facilitate, enhance or foster the institutional training environment. Specifically, Center applicants should provide information on any related NIDDK T32 training programs at the Center institution(s), and describe how the NORC will help to integrate, facilitate and enhance activities of T32-supported trainees. A letter from the PI of any related NIDDK-funded T32 at the Center institution should be included that acknowledges and details how the PI of the T32 intends to promote cohesive interactions between the two programs. Training postdoctoral fellows to conduct research in nutrition and obesity is an associated activity of a NORC. While stipends for fellows cannot be funded from the Center, the establishment of a Center should provide an enhanced environment for research training.

CLINICAL COMPONENT

NORCs are encouraged to support clinical and translational research. A NORC may support clinical research through a clinical component housed in the Administrative Core, through one or more stand-alone research cores, or through some other mechanism. Services should be budgeted through the core in which they would be performed. For a description of the expectations related to clinical research, please see the NORC Administrative Guidelines available at http://www2.niddk.nih.gov/NR/rdonlyres/5483C3CF-7A86-44E6-827D-41DB22969AD4/0/2011_NORC_Guidelines_Final_62911_Final_508.pdf

The NORC must have a central focus or theme(s) that is related to nutritional sciences or obesity. Applicants should consult with NIDDK staff concerning plans for the development of the Center and the organization of the application.

Funding Instrument	Grant
Application Types Allowed	New Renewal Resubmission The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The total amount of funding that the NIDDK expects to award through this announcement is up to $3,400,000 to fund up to a total of three new and/or renewal grants. Two existing P30 Centers are expected to submit renewal applications.
Award Budget	Application budgets are limited to $750,000 direct costs, but need to reflect actual needs of the proposed Center. Within the direct cost cap, up to $150,000 may be requested for the Pilot and Feasibility program.
Award Project Period	The total project period for an application submitted in response to this funding opportunity may not exceed 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.

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)

For profit Organizations

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

Governments

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

Other

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

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

Foreign (non-U.S.) components of U.S. Organizations are notallowed.

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 Program 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.

Only one application per institution is allowed.

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.

Only institutions at which there is an ongoing, strong base of nutrition and/or obesity-related research are eligible. At least 50 percent of the already funded research base in a new application must be Federally-funded. In renewal applications, the NIH-supported research base may be less than 50 percent due, typically, to a growing number of investigators entering nutrition and/or obesity research from other fields.

Applications for NORC grants must propose themes for the center that is relevant to nutrition and/or obesity and is supported by the research projects which comprise the research base for the NORC. The research base grants should be summarized in accordance with the NORC guidelines found at http://www2.niddk.nih.gov/NR/rdonlyres/5483C3CF-7A86-44E6-827D-41DB22969AD4/0/2011_NORC_Guidelines_Final_62911_Final_508.pdf.

Scientific personnel and institutional resources capable of supporting the research base must be available. In addition, the institution and pertinent departments must show a strong commitment to supporting the center. Such commitment may be provided as dedicated space, staff recruitment, salary-support for investigators, dedicated or shared equipment, or other financial support for the proposed center.

Each proposed core must be utilized by a minimum of two federally-funded investigators. A detailed description of each core proposed must be provided, including a detailed budget and budget justification. A well-qualified core director must be named for each core. The description of each core should include a rationale indicating how it will support the center’s research effort in a cost-effective manner. Facilities must be available for the primary needs of the NORC because funds for new construction are not available from the P30 grant.

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.

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

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

The letter of intent should be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: [email protected]

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 all copies of the appendix files must be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: [email protected]

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

• The Introduction to a Resubmission application is limited to 1 page.
• The Research Strategy for the Center’s Background and Overview/Introduction is limited to 12 pages.
• The Research Strategy for the Center’s Research Base is limited to a 6 pages.
• The Research Strategy for the Administrative Core, within the 12 page limit, should include information on the required External Advisory Board. New applications should list the areas of expertise for their board. New applications should NOT identify potential advisory board members by name. Renewal applications should list the names and affiliations of the current members.
• The Research Strategy for the Enrichment Program is limited to 6 pages.
• The Research Strategy for the Clinical Component is limited to 6 pages.
• The Research Strategy for each Core is limited to 12 pages.

The Research Strategy for the Pilot and Feasibility Program is limited to a 6 page overview of the P&F program (to include eligibility criteria, solicitation of applications, criteria and process for selection of awardees) as well as 12 pages for up to four currently funded or approved P/F project being presented (3 pages for EACH project) plus 1 page per P/F project funded in the previous 5 years in renewal applications.

Sufficient pages for required exhibits listing all publications resulting from the funding of the NORC in the last five years as well as sufficient pages for required exhibits to list publications in each core resulting from the use of that core in the past 5 years in Renewal applications. In addition, up to 1 page per research investigator in the research base may be included.

Finally, sufficient pages for all other required exhibits/tables as presented in the Administrative Guidelines for NORCs. These exhibits are available on the internet at http://www2.niddk.nih.gov/NR/rdonlyres/5483C3CF-7A86-44E6-827D-41DB22969AD4/0/2011_NORC_Guidelines_Final_62911_Final_508.pdf.

Biographical sketches, following the instructions in the PHS 398, must be provided for all center members, associate members, P/F applicants, and named core personnel as well as members of external advisory committees and any consultants.

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

NORC applicant institutions must have an existing program of excellence in biomedical research in the areas of basic and clinical research related to the nutritional sciences and/or obesity, and related disorders. To justify Core Center support, the NORC must serve a strong research base that has a consistent and outstanding record in NIH and other peer-reviewed funding. The research base grants must be summarized in accordance with the Administrative Guidelines for NIDDK Nutrition Obesity Research Centers (NORC). (See Application Procedures: http://www2.niddk.nih.gov/NR/rdonlyres/5483C3CF-7A86-44E6-827D-41DB22969AD4/0/2011_NORC_Guidelines_Final_62911_Final_508.pdf).

At least 50 percent of the nutritional sciences and/or obesity, and related disorders research comprising the research base must be supported by Federal Agencies. As stated under the Review Criteria in this document, the existence of an ongoing, strong research base in nutritional sciences and/or obesity, and related disorders will receive strong emphasis during review.

Scientific personnel and institutional resources capable of supporting the research base must be available. In addition, the institution and pertinent departments must show a strong commitment to the Center s support. Such commitment may be provided as dedicated space, staff recruitment, salary support for investigators, dedicated or shared equipment, or other financial support for the proposed Center.

Each core unit proposed for funding under the NORC must be utilized by a minimum of two federally-funded research investigators. A detailed description of each core unit proposed as part of the Center must be provided, including a detailed budget and budget justification. A well-qualified core director must be named for each core proposed.

For each core, include services provided; anticipated usage, and, for renewals, past usage; rationale for how the core will support the NORC members needs; prioritization plan; information on charge-back structure, if utilized; and quality control. Facilities must be available for the primary needs of the NORC Program because funds for new construction are not available.

Promoting interdisciplinary and multidisciplinary collaboration among scientists working within a Center is a major goal of the NORC Program. Each Center application should describe how continuing and new interactions will be fostered and encouraged by the NORC.

Pilot and Feasibility program: Another goal of the NORC is to attract scientists to the fields of nutritional sciences, obesity, and related disorders. Therefore, a Pilot and Feasibility (P/F) Program will be supported to provide modest support for new initiatives or feasibility research studies. In describing the management of the P/F program, include an overview of the plans for soliciting, awarding, and monitoring projects, include eligibility requirements and review strategy.

Further, the NORC may include limited funds to support an Enrichment Program such as seminars, visiting scientists, consultants, and workshops. The Pilot and Feasibility Program and the Enrichment Program of the NORC must be described in the P30 application. For the purpose of this FOA, institutions may submit more than one NORC grant application, provided they are scientifically distinct. However, the NIDDK will not support more than one NORC grant (P30) at any one individual applicant institution.

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

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide,

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 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 components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

The NORC must be an identifiable organizational unit within a single university, medical school, or within a consortium of cooperating institutions with a university affiliation. To qualify for a NORC grant, just as with all other P30 grants, the applicant institution must already have a substantial base of ongoing, independently supported, peer-reviewed research projects related to nutrition and/or obesity and related disorders.

The research base must exist prior to the submission of an application and it is a critical element considered during the peer review process. This currently funded research base provides the major support for a group of investigators who would benefit from shared resources. The body of research described as the research base may include only currently funded, peer reviewed research grants awarded to the applicant institution/consortium. These may be federally or privately funded awards. Training grants and fellowship awards are not considered part of the research base. Focus, relevance, interrelationships, quality, productivity, and, to some extent, quantity, are all considered in judging the adequacy of the research base. Although collaborations with investigators outside the applicant institution/consortium are encouraged, the research base includes ONLY support for the investigators at the applicant institution/consortium.

For institutions with more than one NIDDK-funded P30 Center, grants that utilize other Centers in addition to the NORC should be clearly identified. Annual directs costs for grants whose research aims fall into more than one distinct NIDDK Center may be divided/reduced proportionately, e.g. 50% NORC and 50% Diabetes Research Center.

Grants that are related to nutrition/obesity should be listed first (Exhibit III-A), followed by pending nutrition/obesity-related support (Exhibit III-B), and then other non-nutrition/obesity-related research support (Exhibit III-C) and other pending research support (Exhibit III-D). Grants/projects whose research funding is in a no-cost extension and/or will terminate before the NORC funding period will begin should be included in a separate list. See Guidelines Exhibit III: http://www2.niddk.nih.gov/NR/rdonlyres/5483C3CF-7A86-44E6-827D-41DB22969AD4/0/2011_NORC_Guidelines_Final_62911_Final_508.pdf.

Applicants should consult with NIDDK staff concerning plans for development of a NORC and the organization of the proposed center.

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

Updated other support pages may be submitted prior to the review to better evaluate the research base. This may be in the format of an updated Exhibit III from the Administrative Guidelines for the NORC Program, which is available at http://www2.niddk.nih.gov/NR/rdonlyres/5483C3CF-7A86-44E6-827D-41DB22969AD4/0/2011_NORC_Guidelines_Final_62911_Final_508.pdf. .

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

Significance

Does the NORC address an important problem or a critical barrier to progress in the field? If the aims of the NORC are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? What are the strengths of the center's research base (its breadth and depth) and the relevance and interrelation of the separately funded research projects to the focus/theme(s) of the center? Is there a strong scientifically excellent research base in nutrition/obesity and/or other related conditions/diseases at the Center, which would benefit by the services/programs supported through the NORC? What is the likelihood that the NORC will increase efficiency; promote new research directions and meaningful collaborations among center investigators; facilitate interactions and collaborations among the investigators; and prove cost-effective? In renewal applications, have the benefits of the center been documented in the forms of increased collaboration, new research directions, and cost savings? What are the strengths of the clinical research components of the center?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the NORC? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are the center investigators responsible for the individual research projects willing to interact with each other and contribute to the overall objectives of the NORC? What are the scientific and administrative leadership abilities of the proposed center Director and Associate Director(s) and their commitment and ability to devote adequate time to the effective management of the program? If requested, does the Named New Investigator appear well qualified and eligible for support?

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 the Pilot & Feasibility (P&F) studies submitted for evaluation from applicants eligible for P&F funding? Does the selection process by which the individual P&F studies were selected appear appropriate? Does the center encourage high-risk , innovative ideas through their P&F program? For renewal applications, are data provided to document the outcome of all P&F projects completed in the last five years, including those that failed to lead to further funding? Have the cores provided new methods, techniques, and/or resources and developed ways to support investigators in new areas of nutritional sciences and/or obesity research, as appropriate to the purpose of the core and the research supported by the Center?

Approach

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

How appropriate and relevant are the proposed cores and the modes of operation (such as potential utilization, prioritization of requests for services, cost-recovery, and quality control monitoring)? Will at least two federally-funded research investigators use each core and how significant with their use be? Will the cores provide opportunities not otherwise available to the investigators through other available federally funded and/or institutional resources; represent appropriate cost savings/cost sharing advantage; and stimulate the development of new approaches? Is appropriate administrative organization proposed for the following:(a) coordination of ongoing research between the separately funded projects and the center, including mechanisms for internal monitoring;(b) establishment and maintenance of internal communication and cooperation among the center investigators;(c) mechanism for selecting and replacing professional or technical personnel within the cores;(d) mechanism for reviewing the use of, and administering funds for, the P&F program;(e) management capabilities, including fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities? Is there efficient and effective use and/or planned use of the limited enrichment funds, including the contribution of these activities to the stated goals of the center?

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?

Is there evidence of institutional commitment to the program, including lines of accountability, regarding management of the center grant and the institution's contribution to the management capabilities of the center? Is there clear potential for interaction with scientists from other departments and institutions?

As applicable for the NORC 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.

The following additional review criteria apply to all new and renewal NORC applications:

Foremost, does the research base to be supported by the Center show evidence of a strong and consistent record of productivity and peer-reviewed funding in Center-related research areas? Are the research base and biomedical research cores consistent with the focus/themes of the NORC? Is the requested budget directly correlated to the breadth, quality and relevance to nutrition and/or obesity and related areas of the research base being served by the Center? Do the proposed cores fill a need present in the nutrition and obesity research community, and will they provide services that would otherwise be unavailable, or be more cost-effective to conduct centrally? Is the necessary technical and analytical expertise available? Does the application demonstrate ability to monitor use and utility of the cores, and provide approaches to ensure continuing development and evolution of services as needs of the community change? Do the existing Centers show clear evidence of successful implementation of a recharge structure to support expanded and/or evolving Center activities? Do the new proposals document a clear intent to implement a recharge structure to support expanded and/or evolving Center activities?

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 NORC 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, as follows:

Research Base:

• Does the Center show evidence of a stable or growing research base with strong and consistent record of scientific excellence and achievement reflected in an outstanding level productivity and continuing success in securing peer-reviewed research funding?
• Does the Center show evidence of fostering multi-disciplinary collaborations among Center investigators?

Biomedical Cores:

• Is there a significant list of publications arising from each core that are relevant to nutrition/obesity and related conditions in renewal applications?
• Is there a significant fraction of papers that a) acknowledge the Center and b) do not have core personnel as co-authors?
• Are the number and listing of Center investigators who have used the core and resultant key advances consistent with the level of core investment?
• Do the number and listing of investigators who have used the core multiple times indicate satisfaction and continuing need for core services?
• Are there sufficient numbers of users who are not core directors/personnel or their collaborators?
• Are the use, utility, quality control, and cost-effectiveness of each core appropriate and adequately described?
• Are the numbers of services/tests offered by each core indicative of a growing need and sufficient to justify continued support, and if not, has the Center provided evidence of ability to evolve cores to meet changing needs of the research community?
• If a research core has been discontinued during a prior funding period, is there a description/justification of the process for discontinuing the referenced research core?
• Is the capacity of each core with current resources sufficient to serve the needs of the Center community?
• Does the Center provide evidence of Program Income and sufficient institutional support?

Administrative Core:

• Has the administrative structure proven effective?
• Has the enrichment program been effective?
• Are the Director(s) appropriately qualified to lead the NORC?

Pilot & Feasibility Program:

• Are the numbers and types of P&F awards well justified?
• Are papers generated under these awards, projects successfully funded with independent grants, and key advances linked to these awards well documented and consistent with the level of support provided?

Clinical Component:

Does the NORC provide meaningful support for patient-oriented research in a manner that fosters clinical/translational research? Are the services appropriate for the NORC Center members/research base?

Revisions

Not Applicable.

As applicable for the NORC 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 the NIDDK , 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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
• 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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NDDK Advisory Council . 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 the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement.

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

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: [email protected]

Mary E. Evans, Ph.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 681
Bethesda, MD 20892-5450
Telephone: (301) 594-4578
FAX: (301) 480-8300
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: [email protected]

Ms. Sharon Bourque
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 707
Bethesda, MD 20892-5456
Telephone: (301) 594-8846
FAX: (301) 594-9523
Email: [email protected]

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

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