Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)


Funding Opportunity Title

Cystic Fibrosis Research and Translation Core Centers (P30)

Activity Code

P30 Center Core Grants

Announcement Type

Reissue of RFA-DK-09-009.

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-DK-11-004

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 Funding Opportunity Announcement (FOA) invites new and renewal applications for Cystic Fibrosis (CF) Research and Translation Core Centers.  CF Research and Translation Core Centers are designed to support both basic and clinical research on Cystic Fibrosis (CF).  CF Research and Translation Core Centers support three primary research-related activities: Research Core services; a Pilot and Feasibility program; and an Enrichment program. Core Centers provide shared resources to support research to develop and test new therapies for CF and foster collaborations among institutions with a strong existing research base in CF.  The NIDDK currently supports 5 CF Research and Translation Centers located at institutions with documented programs of research excellence in basic and clinical CF research.  Information about the CF Research and Translation Centers may be found at the following URL:
http://www2.niddk.nih.gov/Research/Centers/CenterPrograms

Key Dates
Posted Date

April 1, 2011

Letter of Intent Due Date

May 31,2011

Application Due Date(s)

June 30, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October - December, 2011

Advisory Council Review

January, 2012r

Earliest Start Date(s)

April, 2012

Expiration Date

July 1, 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.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

1. Purpose

Cystic Fibrosis (CF) is one of the most common, life-limiting genetic diseases, and is estimated to affect 30,000 Americans. Patients with CF have inherited two mutated copies of the gene, cystic fibrosis transmembrane conductance regulator (CFTR), in every tissue of the body.  Although lung disease is the primary cause of death in CF, multiple organ systems have altered functions including the lung, liver, pancreas, bone, sweat glands, and gastrointestinal and reproductive systems.

Treatment of the pancreatic symptoms and the lung infections has extended median survival in the United States to the mid thirties.  All states in the US now screen for CF at birth to enable presymptomatic support for nutrition and preventing infections that may further improve the quality of life for these patients.  Children identified at birth avoid the malnutrition that has been the common presenting symptom for CF.  In addition, these patients could benefit from many new forms of therapy that are being developed to aggressively eradicate bacterial colonization of the lung, control inflammation and lung damage, treat diabetes and liver disease and provide nutritional support.

In addition to treating the symptoms of CF, researchers are investigating molecular and pharmacologic methods to treat the underlying cause of CF.  Screening of small molecules has identified lead molecules that either increase expression, processing, trafficking or function of the CFTR protein.  In addition, other molecules that bind to CFTR are being identified and their role in CFTR trafficking and activation is being studied. Gene therapy approaches to deliver a normal CFTR gene are also being pursued.  New vectors with less toxicity have been developed.  The availability of improved animal models such as the pig and ferret, which better mimic the human disease, aid in the testing of these new therapies.  These encouraging findings suggest that collaborative efforts between basic and clinical researchers could foster the translation of novel basics research findings into preclinical testing in animal models, and forward to clinical applications.

2. Center Structure and Activities

The NIDDK CF Research and Translation Centers are part of an integrated program of research support designed to enhance multidisciplinary research in pathogenesis and treatment of cystic fibrosis. The goal of these Cystic Fibrosis Research and Translation Core Centers is to support research to develop and test therapies for CF.  These Centers will provide resources for communication and collaboration between basic and clinical researchers. CF Research and Translation Core Centers support three primary research-related activities:(1) Research Core Services that provide shared resources to enhance the efficiency of research and foster collaborations within and among institutions with strong existing bases of research on cystic fibrosis; (2) a Pilot and Feasibility Program designed to foster the development of new investigators and to provide seed-support for innovative high-risk projects; and (3) an Enrichment Program to promote interdisciplinary interation and training of investigators.

Institution and Research Base

A CF Research and Translation Center must be an identifiable unit within a single institution such as a university medical center, or within a consortium of cooperating institutions with complementary research bases. In either case, the Center applications must be associated with an existing program of excellence in biomedical research in basic and clinical research in CF.  Program excellence is measured through a consistent and outstanding record of productivity and peer-reviewed research funding in CF and related research areas.  A high level of integration and close collaboration among Center personnel from diverse scientific disciplines is an important feature of a successful CF Research and Translation Center. Accordingly, the applicant should clearly state considerations for Center membership with specific reference to the potential of members to form interactive, collaborative and synergistic relationships.  Center applicants should identify one or more central themes or focus areas that link Center investigators and their research programs. These themes must be within the mission of the NIDDK.

CF research often requires the use of specialized technologies and resources to support a cohesive research effort. The goal of the Center is to make state-of-the-art technologies and resources readily accessible to a broad spectrum of investigators working in CF.

Administrative Core

CF Research and Translational Center 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.  CF Research and Translational Centers are encouraged to develop a Center website to communicate available resources to the participating Institution(s).  The Core Center Director should provide at least 1.2 calender month effort on the Administrative Core and a total of 2.4 calendar month 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.

Biomedical Research Core

A biomedical research core is defined as a shared resource that provides essential services, techniques, or instrumentation to Center participants enabling them to conduct their funded individual research projects more efficiently and/or more effectively.  Cores provide specialized technologies and expertise needed to accomplish the stated goals of the Center toward the development of therapies for CF. Each core should provide services to multiple funded research projects.  Centers may propose either Institutional Cores or Regional/National/International Cores. Whereas Institutional Cores support research at a single institution or a set of cooperating institutions, Regional/National/International Shared Resources serve specific scientific communities on a regional, national, or international level. A new category of research base for cores that are used as a regional, national, or international resource should be considered the "extended research base". The extended research base for a regional, national or international core could include all investigators who might expect to use the core in some way. This might include investigators who would be expected to fully compensate the core service through a charge-back, and thus would not be obtaining direct financial assistance from the Center. The list could include investigators who use the core services but otherwise have no collaborative interactions with other Center investigators. The extended research base should be defined as an entity separate from the institutional research base. For review purposes, it should be evaluated as part of the proposed International/National/Regional core, in order to distinguish it from the local institutional research base.  Examples of types of biomedical core resources that would be considered responsive to this Funding Opportunity Announcement include:

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 the 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 Center research cores may be an institutional shared research core.  In such cases, the research core support provided by the CF Research and Translation Center should be proportional to the use of the institutional research core by Center 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 CF Research and Translation Center 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 CF Research and Translation Center 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 CF investigators with other sources of peer-reviewed support.  Participants in the CF Research and Translation Center program are encouraged to become fully integrated into, and synergistic with, other NIDDK- and NIH-funded 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 related NIH roadmap activities, and any related NIDDK-funded Center programs such as the Nutrition Obesity Research Center (NORC) Program http://www3.niddk.nih.gov/centers/norc.shtml).  Applicants should provide information on other programs supporting related resources at their institution and describe the nature of synergy and integration between the CF Research andTranslation Center and these other activities.  Applicants must also clearly describe how duplication or redundancies of effort, services and resources will be avoided.

Center Evolution: Centers must document policies and procedures for ensuring continuing evolution of core services in response to changing needs. New technologies or services might appear that should be supported, existing technologies might become less important, or economic changes might obviate the need for core services, such as the availability of cost-effective commercial services or core services provided by the research institution. Cores should address the issue of allocation of resources to development of new technologies versus provision of services with existing technologies. In addition, cores must have well-defined policies to insure that intellectual property is identified and appropriately protected, but that intellectual property issues do not impede sharing of resources.

Pilot and Feasibility Program

The CF Research and Translation Core Center Pilot and Feasibility (P&F) program provides seed support for new and innovative research projects directed at basic biomedical, clinical and translational research questions relevant to cystic fibrosis. To be considered a viable P&F program, the Center must support a minimum of two pilot projects annually, up to a maximum of four pilot projects.  It is anticipated that up to $75,000 in direct costs per year for up to two years will be provided for the majority of approved P&F projects.  Efforts to increase the number of P&F awards and availability of funds for the program through the use of program income or alternative funding sources are particularly encouraged. 

The P&F program is particularly directed at new investigators and established investigators new to CF research. Established CF investigators pursuing high impact/high risk projects or projects that are a significant departure from their usual work are also eligible for support under the CF Research and Translation Core Center P&F program.  This Program should be integrated into the overall research goals of the Center and make use of the resources provided by the Cores.  P&F programs may also be structured to provide support for establishing interdisciplinary collaborations and to help forge new partnerships between basic scientists and clinical researchers.  In general, NIDDK expects CF Research and Translation Centers to solicit investigators at affiliated hospitals or institutions to participate in the Center P&F program.  The applicant should provide details on how F&A costs for P&F projects with partnering institutions will be handled. While the distribution of P&F funds to be used in each award category is ultimately at the discretion of the Center P&F committee, it is expected that the Center P&F program will, where possible, place particular emphasis on funding innovative clinical and translational research projects.

Enrichment Program

The CF Research and Translation Core Center enrichment program should be designed to advance translational research in cystic fibrosis and promote scientific exchange among investigators with research interests in these topic areas, and to enhance interactions between CF 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 CF Research and Translation Core Center for Center participants, and document ways the Center may facilitate, enhance or foster the institutional training environment.  Specifically, Center applicants should provide information on related T32 training programs at the Center institution(s), and describe how the CF Center will help to integrate, facilitate and enhance activities of T32-supported trainees.  A letter from the PI of any related NIH-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 cystic fibrosis is an associated activity of a CF Research and Translation Core Center.  While stipends for fellows cannot be funded from the Center cores, the establishment of a Center should provide an enhanced environment for research training.  Just as in the case of funding for individual research projects, funding for fellowships should be sought from NIH NRSA, institutional training grants (e.g. T32, T35) and individual fellowships (e.g. F30, F32), and other sources such as private foundations, and commercial companies.      

Section II. Award Information
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 number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

NIDDK intends to commit $2M for 2 awards in FY 2012..

Award Budget

Application budgets are limited to $750,000 direct costs.  Equipment costs and indirect costs on subcontracts are not included in the $750,000 direct cost cap.

Award Project Period

The maximum project 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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

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

Required Registrations

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.

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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/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.

Because a CF Research and Translation Core Center has a large and complex administrative structure, the Project Director/Principal Investigator must have strong leadership abilities and demonstrated proficiency in managing large, multi-component projects.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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 one application per institution (normally identified by having a unique DUNS number of NIH IPF number) is allowed.  The research base should not overlap signifcantly with other NIDDK-funded Centers. 

An existing program of biomedical research in cystic fibrosis is required.  This research base must consist of NIH and other peer-reviewed funded research projects and be substantial to justify the requested Core support.  A clinical research base is not required but would be considered a strength.  The research base for the Center must consist of a minimum of $2,000,000 total costs per year of peer reviewed research projects relevant to the development of therapies for CF.  Core support should not be included in the research base.  Applications that do not document this level of research project funding will be returned without review.  Suggestions for describing and presenting this research base in the application are included in the Administrative Guidelines for the CF Research and Translation Core Centers.    

Section IV. Application and Submission Information

1. Address to Request Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the 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 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, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: 301-594-8897
Email:  fc15y@nih.gov

Application Submission

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

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

At the time of submission, two additional paper copies of the application and 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, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: 301-594-8897
Email:  fc15y@nih.gov

Page Limitations

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

Supplemental Instructions for the Preparation of CF Research and Translation Core Centers

Content and order of information to be provided should be presented in the form and format as described in the CF Research and Translation Core Center administrative guidelines (http://www.niddk.nih.gov/fund/other/guidelines.pdf) with adjustments as indicated in this FOA.  An overview of the structure of a responsive Center application is provided below.  Every effort should be made to provide information in tabular or chart form where indicated in the guidelines to facilitate application preparation and review.  Failure to comply with these instructions may result in return of the application without review.

SECTION 1:  CENTER OVERVIEW

• Face Page, Descriptive Abstract, Key Personnel and Table of Contents should be prepared as per standard instructions.

Budget

1.  Detailed Budget for Initial Budget Period (398- Form Page 4)

2.  Budget for Entire Proposed Project Period (398- Form Page 5);

3.  Consolidated budget for first year of requested support (See Guidelines Illustration I;

     budgets for each individual Core should immediately precede the narrative for each Core)

4.  Distribution of Professional Effort (see Guidelines Illustration II)

Biographical Sketch

• Biographical Sketches (in alphabetical order):  for all CF Research and Translation Core Center investigators (key personnel, research base investigators, consultants and collaborators (PHS 398- Form Pages)

Biographical sketches for principal investigators on proposed P&F projects should be included within the P&F program section.

• Summary of total current and pending support of all Center participants, including levels of professional effort.  Some institutions may have multiple NIDDK-funded centers.  In those cases, investigators who participate in multiple centers should identify their primary center affiliation to aid NIDDK in matching center resources to the research base being served.  Research grant support that is listed as 'primary' for the CF Research and Translation Core Center, should not be reported as part of the primary research base for any other NIDDK Center grants (i.e. each research grant should be reported as part of the primary Research Base on only one NIDDK Center grant application).  List 'primary' support related to diabetes first, followed by other related research support (see Guidelines Illustration III).

• Resources Format Page:

Facilities and Major Equipment: general overall description of research facilities (space, equipment, collaborations, etc.) and the major, shared pieces of equipment to be used by Center members should be provided.

Specific core facilities, equipment, and special resources should also be listed in each core component.

Research Plan

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

• Specific Aims (limited to 1 page): Provide the broad, long-range objectives and goals of the proposed CF Research and Translation Core Center.

• Research Strategy (limited to 12 pages):  This narrative section summarizes the overall plan for the proposed or established multi-component Center.  The multi-component application should be viewed as a confederation of interrelated research resources that are complementary to one another.  This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall Center – by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems.  As the strategy develops, each individual research component/core should be cited briefly as to its place in the overall scheme.  Summarize the special features in the environment and/or resources that make this application strong or unique.  If the application is a renewal, the Center Program Overview section should also highlight past performance and the major accomplishments from the prior funding period as described in the PHS 398 Instructions.  For Renewals: Changes from the original Center design should be highlighted.

SECTION 2:  ADMINISTRATIVE COMPONENT (Research Strategy is limited to 6 pages)

Description (PHS 398- Form Page 2),Key personnel (PHS 398- Form Page 2 cont’d) should be prepared per standard instructions

Detailed Budget for Initial Budget Period

• Budget with comprehensive budgetary justifications (PHS 398- Form Page 4); funds requested for the P&F and enrichment programs should be included in the "other expenses" category of the budget for the Administrative Core.

• Biographical Sketches: Director and Associate Director(s) (PHS 398 Form page)

Research Plan

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

• Specific Aims (limited to 1 page): Describe the broad, long-range objectives and goals of the Administrative structure within the context of the proposed Center.

• Research Strategy (limited to 6 pages):  Presentation of the administrative structure; Relationship and lines of authority and sanction by appropriate institutional officials; Description of the process that would be used to recommend a successor to the Director, if needed; Committee structure (include External and Internal advisory boards and the pilot and feasibility program oversight committee; Description of plans for website development, maintenance and curation; General overall description of facilities and institutional commitment; Other Considerations (include listing of other relevant Centers and cores at the institution and affiliated hospitals, and plans to integrate, harmonize and eliminate redundancies in activities)

SECTION 3:  BIOMEDICAL RESEARCH COMPONENT

• Biomedical research base (Research Strategy is limited to 6 pages): Provide an overview of ongoing research and the impact of the Center on this research. Include an overview of the current basic and clinical research in cystic fibrosis at the institution(s). An appropriate and clear presentation of the ongoing research base is critical since it will show the research focus of the CF Research and Translation Core Center and the interrelationships and potential for collaborations among investigators.  Since the research base projects will already have been peer- reviewed, the quality of the individually funded projects will have been established and will not be re-evaluated. Provide sufficient detail to assist reviewers in judging the extent and the interrelatedness of ongoing research. Grouping the research base into areas of emphasis for the Center is advised. 

New applications: Emphasize the anticipated impact of the establishment of a CF Research and Translation Core Center on the research base. Include an indication of how the establishment of a CF Research and Translation Core Center will provide added dimensions and new opportunities for cystic fibrosis  and related research, along with increased cooperation, communication, and collaboration among investigators.

For Renewals: Progress including description of significant findings and new participants. 

Research Project Descriptions (limited to 1 page per Investigator): Organize the narrative presentation of the research base to emphasize the focus of the research and the interrelationships of the CF Research and Translation Core Center investigators. Provide a narrative description of no more than one page per research base investigator.  These narratives should include: (1) the grant number, title, and a few descriptive sentences, and (2) a list of the core(s) used with a brief sentence indicating what aspect of the research justifies the use of each core. Include ONLY those grants awarded to investigators at the applicant institution or consortium, not to investigators at other locations, in the description of the research base. It is particularly important to provide a few sentences indicating the relatedness of a cited grant to research in cystic fibrosis when this is not readily apparent from the title of the grant.

• Biomedical research cores (present each core separately; Research Strategy limited to 12 pages per core)

Description (PHS 398- Form Page 2),Key Personnel (PHS 398- Form Page 2-cont’d), Budget with justifications (PHS 398- Form Page 4) and Biographical sketches: Core Director and key personnel (PHS 398- Form Page) should be prepared as per standard instructions.

Research Plan

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

• Pilot and Feasibility Program

Description (PHS 398- Form Page 2),Key Personnel (PHS 398- Form Page 2-cont’d),Budget with justifications (PHS 398- Form Page 4); justify any changes for future years, Biographical sketches: Program Director and Committee (PHS 398- Form Page) should be prepared as per standard instructions

• Enrichment Program (limited to 6 pages, exclusive of form pages)

SECTION 4: CENTER-RELATED INFORMATION

• Suggested Illustrations for Renewal Applications: Publications Citing Support from this Center (see Guidelines Illustration IV; include PMCID numbers)

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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

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

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Overall Impact - Overall

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

Scored Review Criteria - Overall

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

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center 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?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  Do(es) the PD/PIs have demonstrated expertise in directing a multicomponent project? 

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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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 Center involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  Are there appropriate institutional commitments to the Center, including lines of accountability regarding the management of the Core Center grant and a commitment to establish new positions as necessary? 

Additional Review Criteria - Overall

As applicable for the Center 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 considerations apply to all new and renewal CF Research and Translation Core Center applications. 

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.

The following evaluation criteria will be used to assess the progress of renewals of the CF Research and Translation Core Center applications. Renewal applications should demonstrate productivity as following:

Research Base:

Pilot & Feasibility Program:

Revisions

Not Applicable

Additional Review Considerations - Overall

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.

2. Review and Selection Process

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:

Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

Scientific/Research Contact(s)

Catherine McKeon, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8810
Email: mckeonc@mail.nih.gov

Peer Review Contact(s)

Francisco O. Calvo, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8897
Email: fc15y@nih.gov

Financial/Grants Management Contact(s)

Christine Gill
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-2816
Email: cg313@nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


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