Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov)

Components of Participating Organizations
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov)

Title: NIDCD Clinical Research Center Grant (P50)

Announcement Type
New

Update: The following update relating to this announcement has been issued:

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-10-047

Catalog of Federal Domestic Assistance Number(s)
93.173

Key Dates
Release Date: December 9, 2009
Letters of Intent Receipt Date(s):  30 days before planned application submission date.  
Application Receipt Dates(s): February 1, 2010, June 1, 2010, October 1, 2010; February 1, 2011, June 1, 2011, September 30, 2011; February 1, 2012, June 1, 2012 and October 1, 2012. 
Peer Review Date(s): May/June 2010; September/October 2010; January/February 2011; May/June 2011; September/October 2011; January/February 2012; May/June 2012; September/October 2012; January/February 2013
Council Review Date(s): October 2010; January 2011; May 2011; October 2011; January 2012; May 2012; October 2012; January 2013; May 2013
Earliest Anticipated Start Date:  December 2010; April 2011; July 2011; December 2011; April 2012; July 2012; December 2012; April 2013; July 2013
Additional Information To Be Available Date (Url Activation Date): Not applicable.
Expiration Date: October 2, 2012

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing   
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Studies with normal human subjects (e.g., those without a communication disorder) may be included in the research only when data from normal controls are essential for interpretation of the results.

Non-human research will be allowed on a NIDCD P50 grant on rare occasions.  Non-human research is limited to 1 subproject and only if translational or serves as a platform for translational research.  Prior approval from the designated NIDCD Program Director and the NIDCD P50 Coordinator must be obtained and documented in the cover letter.

Core support can be requested as part of a P50 application to provide essential resources required by multiple subprojects. Requests must be carefully justified and not be used to acquire additional support that duplicates existing resources already at the institution.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity announcement (FOA) will use the NIH specialized center (P50) grant mechanism. Applicants are solely responsible for planning, directing, and executing the proposed project. This mechanism provides funding for a broad range of research and developmental activities and is intended to promote multidisciplinary clinical research. 

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

2. Funds Available

The NIDCD Clinical Research Center grant application may request up to 5 years of funding.  Budgets for new P50 applications are limited to $1,500,000/year direct cost (DC).  Competing renewals (type 2) P50 grant applications may request budgets (DC) that are no greater than 10% above the budget (DC) of the last year of the existing grant. Annual budget increases should not exceed more than NIH allowances at the time of submission of the application. Salary levels in all years are limited to the NIH maximum rate.  See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-035.html

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation.  See NOT-OD-05-004.

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

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Foreign institutions and organizations are not eligible to apply for the NIDCD Clinical Research Center Grant (P50).

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution 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.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below.  When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and renewal applications are permitted only a single amendment (A1).  See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Original new and renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2).  For these “grandfathered” applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals.  Applicants may submit a renewal application, but renewal applications may not exceed the stated caps.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs 

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the Research Plan, entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date(s): 30 days before planned application submission date.  Application Receipt Date(s): February 1, 2010, June 1, 2010, October 1, 2010; February 1, 2011, June 1, 2011, September 30, 2011; February 1, 2012, June 1, 2012 and October 1, 2012.
Peer Review Date(s): May/June 2010; September/October 2010; January/February 2011; May/June 2011; September/October 2011; January/February 2012; May/June 2012; September/October 2012; January/February 2013
Council Review Date(s): October 2010; January 2011; May 2011; October 2011; January 2012; May 2012; October 2012; January 2013; May 2013.
Earliest Anticipated Start Date(s): December 2010; April 2011; July 2011; December 2011; April 2012; July 2012; December 2012; April 2013; July 2013

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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.

The letter of intent is to be sent electronically or by mail to the NIDCD P50 Coordinator named below by the date listed in Section IV.3.A.

Lana Shekim, Ph.D.
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd; EPS 400C
MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-5061
FAX:  301-402-6251
Email:  shekiml@nidcd.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, three signed photocopies and 5 identical CDs containing appendix materials, if appropriate, 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application must be sent to:

Melissa J. Stick, Ph.D., M.P.H.
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd, EPS 400C
MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-8683
FAX:  (301) 402-6251
Email:  stickm@nidcd.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt/ date(s) described above (Section IV.3.A.). If an application is received after that date, the application will not be reviewed.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

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. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements

The NIDCD Clinical Research Center Grant is a multi-component award which must consist of at least 3 subprojects and related cores.  A complete application will include a Project Overview, limited to 12 pages.  Each individual subproject and core are limited to the same page limitations as an R01 application; e.g., 12 page limit for their Research Strategy section.

Research Grant Table of Contents (Form Page 3 PHS 398):  Prepare a detailed table of contents that will enable reviewers to find specific information readily. Present the subprojects first and the cores last. Identify each subproject by title, assign each subproject a number and each core a capital letter that reflects the order in which the subprojects and cores are presented in the application, and provide the name of the responsible investigator for each component. Number the pages consecutively. Indicate the beginning page numbers for each subproject, core, and their respective budgets.

Budget (Form Pages 4 and 5 PHS 398):  Reproduce the standard budget forms, pages 4 and 5, as necessary to allow preparation of both a "Detailed Budget for First 12-Month Budget Period" and a "Budget for Entire Proposed Project Period" for a composite budget, each subproject, and each core. All budgets (composite, subproject, core, and consortium/contractual) will be in this one section, placed in the same order that the subproject and cores are listed in the table of contents, and paginated accordingly. The complete budget section should include the following:

Composite budget for first 12-month budget period.  The composite budget is presented on Form Page 4, PHS 398. For each of the applicable budget categories (PERSONNEL, CONSULTANT COSTS, EQUIPMENT, SUPPLIES, TRAVEL, PATIENT CARE COSTS, CONSORTIUM/CONTRACTUAL COSTS, AND OTHER EXPENSES), give the amount requested for each subproject and core and provide subtotals where appropriate. If contractual arrangements or "purchased services" involving other institutions or organizations are anticipated, include both direct and indirect costs associated with such participation in the CONSORTIUM/CONTRACTUAL COSTS category.

Composite estimates for all years of support requested. Use Form Page 5, PHS 398. Present composite budget estimates by category for all years of support requested.

Person months distribution among subprojects: As an aid to reviewers, the information on the person month of personnel should be presented in tabular format.

Individual first and future years’ budget estimates. Use the standard budget forms contained on Form Pages 4 and 5 of the PHS 398 to present the first budget period and future years’ budgets for each subproject and core. Place these after the aforementioned pages (the two pages of composite budgets and the page that illustrates the person month distribution among subprojects and cores) in the order the subprojects and cores are presented in the table of contents and in the application. Where appropriate, provide subtotal costs for calculations that are not obvious, such as: 2 blood samples x 40 patients x 2 outpatient visits @ $20/sample = $3,200. Explain non-inflationary cost increases added in future years. Provide explicit explanations to justify individual personnel and each major item requested in each of the other categories. Include budget justifications on the appropriate budget page (Form Page 5 PHS 398) even though explanatory information may be provided, or seems apparent, in the text of the research subproject or core.

Biographical Sketch Format Page (PHS 398):  Prepare biographical sketches as described in PHS 398 application guidelines and place them, in alphabetical order, in one section immediately after the budget section. Biographical sketches are required for all professional personnel (including consultants) who participate in the research subprojects and cores. NIH encourages applicants to limit the list of selected peer-reviewed publications or manuscripts to no more than 15. 

Resources Format Page (PHS 398):  If necessary, use continuation pages to describe multiple facilities and to explain geographic relationships.

Project Overview

Overall Project Description:  Provide an overview of the entire program and describe the central theme and goals of the Clinical Research Center (P50). Provide the rationale for the proposed research program. Explain the research plan for achieving the objective(s) of the overall program and how each subproject and core relates to that overall plan.  Provide a project overview of the proposed Center and a brief description and/or aims of each subproject and core.  Indicate any prior collaborative arrangements between investigators in the group; emphasize the events that led to the current application; predict the anticipated advantages that would be gained by including the research in the proposed program; describe the overall theme of the center and how the subprojects are related to that theme; and, describe the multidisciplinary nature of the proposed research.  Include the following:

Organizational and Administrative Structure:  Describe in detail the chain of responsibility for decision-making and administration, beginning with the principal investigator and including the investigators (key personnel) responsible for the research subprojects and cores. Indicate where, in the chain of responsibility, advisory groups of internal and (or) external consultants would be used, and describe their function. (Letters of agreement from consultants should be included in the application).

Specific managerial responsibilities: Indicate who would be responsible for assisting the Principal Investigator with the day-to-day administrative detail, research patient care, program coordination, and the planning and evaluation of the program.

Relation of the Clinical Research Center organization and administration to the applicant institution: Describe the relation between the proposed Clinical Research Center and other existing research, academic, and administrative units of the applicant institution, such as centers, institutes, departments, and central administration.

Summary Report of Progress:  Renewal (formerly competing continuation) applications must include a progress report that highlights achievements of the overall Clinical Research Center since the last competitive review. A specific progress report is required for each subproject and core unit in its respective section of the application. The progress report must include the following information:

a brief summary of major accomplishments that can be attributed to the grant and a brief explanation of how these accomplishments have contributed to further the stated objective(s) of the grant;

a list of all publications and manuscripts accepted for publication that have resulted from the grant (do not list manuscripts submitted or in preparation);

a list of any changes in the professional staffing since the last competitive review;

a tabular list of subprojects and cores that have been discontinued, completed, or modified since the last competitive review, identified by number and title, with a brief explanation of the reasons for the changes; and

a list of subprojects and cores in the ongoing program, with the amount of current funding for each and the requested funding for the first budget period of each subproject and core that would be continued.

Consortium/contractual arrangements: If the proposed program includes requests for funds for research activities that involve institutions other than the applicant organization, the program is considered a consortium effort. Such cooperative activities may be included in a P50 application.  Follow the PHS 398 Guidelines in preparing this section.

Format for the Presentation of a Component Research Subproject:  Describe each subproject in the same detail required for the traditional, individual research grant (R01) application so that the scientific merit can be judged on the basis of the written application alone. Keep in mind that the application will be reviewed by experts who will judge, collectively, all areas represented in the application but who may not be familiar, individually, with each area of research proposed. Therefore, the description of a subproject should be explicit enough to enable experts in related areas to understand the main thrust of the subproject and how the subproject relates to the main theme of the program. Follow the instructions of the PHS 398 Guidelines.  Each subproject is allowed 1 page for the specific aims and 12 pages for the research strategy section.  Title and number each subproject so it can be readily distinguished from other subprojects.  

Format for the Presentation of a Component Core:  A "core" is defined as a resource for the program that provides centralized services to more than one research subproject. Actual research is not conducted in a core. The following information must be provided whether the proposed core is new or existing [e.g., as in the case of an institution with an existing Core Center (P30) grant that is appropriate to the P50 application].

Title of core: Title and assign an alphabetic designation to each core so that it can be readily distinguished from the subprojects.

Names and titles of investigators: Provide the name, academic title, and department or organization of the core leader and each participating investigator on the cover page.  

Description of core: Explain the function of the core as a resource for the P50. Describe the facilities, techniques, and professional skills that the core would provide.  As justification for the core, indicate how and which specific subprojects would utilize the resources of the core.  Estimate the percent time and effort that core personnel would allocate to individual subprojects.

Progress report: For a renewal application, summarize the utilization and value of each core during the preceding period of support.

Resubmission Application:  When submitting a resubmission application, an Introduction section is required and should summarize any substantial additions, deletions, and changes made. A separate one page Introduction is allowed for the Project Overview section as well as each subproject and core.  Include responses to criticisms in the previous summary statement. Changes within the text of the research plan should be highlighted by vertical lines in the margin, bracketing, indenting, or changing of typeface. Incorporate in the progress report any work done since the prior version was submitted.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations.  An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDCD and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

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

The NIDCD P50 must meet 4 essential criteria listed below:

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

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  Is the research to be conducted clinical as defined above (page 4)? Is the subproject unambiguously related to the central unifying theme? Are there synergy and substantial interaction between this subproject and the other subproject?

Investigator(s), Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, 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?  For applications designating multiple PDs/PIs, is the rational for choosing multiple PDs/PIs clearly described?  Are communication plans, the process for making decisions on scientific direction and procedures for resolving conflicts clearly presented?  Are the PDs/PIs and other collaborators’ roles and other administrative and technical and scientific responsibilities clearly delineated?

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 synergistic and substantial interactions between this subproject and other subprojects evident?  Does this subproject contribute to the overall P50 multidisciplinary approach to the central theme?

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Does this subproject contribute to the overall P50 multidisciplinary approach to the central theme? 

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? 

Overall Clinical Research Center Review Criteria

Each P50 must have a well-defined central unifying theme with three or more meritorious subprojects for the duration of the project period and may contain appropriately justified cores that support two or more subprojects. Whereas subprojects are scored individually, the overall P50 score is an overall evaluation, and not an average of the individual subprojects’ scores.  Program staff may consider deletion of a weak subproject when recommending award of the remaining reduced scope yet strong P50. The IRG will evaluate the relationship and contributions of the combined subprojects and cores to the overall theme of the Clinical Research Center. In addition to core review criteria listed above, factors include overall scientific considerations, leadership, and administration, as detailed below. However, the most important consideration will be the scientific merit of the research plans, as judged in the individual subprojects.

Scientific Considerations:

What is the scientific gain from combining the individual subprojects/cores into a center?

How cohesive are the subprojects of the center, their interrelationship and coordination?

What are the past accomplishments of the center or the demonstrated ability of the core personnel in conducting similar programs?

Leadership and Administration:

Is the principal investigator capable of managing the overall scientific effort and budget?

Is there evidence of established leadership in scientific research and demonstrated capabilities in program administration?

Are there internal and/or external advisory committees to assist in making scientific/administrative decisions and evaluating progress and direction?

Are there planned meetings or other methods to facilitate the interaction of participating investigators and assure a cohesive program (sharing and evaluation of results, new ideas)?

How is the academic environment?  Are there sufficient resources where the research will be conducted, including space, equipment, human subjects, or other resources as required for the overall center?  Is there potential for interaction with scientists from other departments and disciplines?

What is the institutional commitment to the requirements of the program, including fiscal responsibility and management capability of the institution to assist the principal investigator and his or her staff in following DHHS and NIH policy?

Is there evidence of administrative planning and leadership capability to provide for internal quality control of ongoing research, allocation of funds, enhancement of internal communication and cooperation among the investigators involved in the program and replacement of the principal investigator if required on an interim or permanent basis?

Do the overall leadership and administration demonstrate full consideration of human subject protection, inclusion of women, minorities and children and biohazard issues as reviewed in the individual components?

Review Criteria for Individual Cores

Utility of the core to the Clinical Research Center: Does each core provide essential facilities or service for two or more subprojects judged to have substantial scientific merit?

Facilities and services: What is the quality of the facilities and services provided by this core (including procedures, techniques, quality control, and criteria for user priority)?

Personnel: Are the qualifications, experience, and commitment of the personnel involved in the core appropriate and adequate?

In the case of a renewal application, the progress made during the past period of funding is also an important consideration in the review.

Additional Review Criteria 

As applicable for the project proposed, (overall Center program and individual subprojects) reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

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

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

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.

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.

Resubmission Applications.  When reviewing a Resubmission application (formerly called an amended application), 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.

Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.  Reviewers will evaluate whether or not the applicants have demonstrated adequate progress on projects that are ongoing. Have the applicants addressed any difficulties in achieving the previously proposed specific aims? Are the new research goals logical extensions for the project? Is there clear evidence that such a project reached a human end-point during the current funding period? Will the continuation of the project lead to new translational findings? Is there sufficient evidence if the investigative team, especially the project co-leaders, established a productive working relationship during the current performance period? Is their productivity documented by published or submitted manuscripts describing their previous findings?

Revision Applications.  When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project.  If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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.

Additional Review Considerations 

As applicable for the project proposed, reviewers will address 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.

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

Select Agents  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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications.  The following will be considered in making funding decisions:

NIH considers the following in evaluating Center grant applications:

Section VI. Award Administration Information


1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

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. See Also Section IV.5. Funding Restrictions.

A formal notification in the form of a Notice of Award (NOA) will be provided to the applicant organization. The NOA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Prospective applicants are encouraged to contact the relevant scientific program directors.  Contact information can be found at this URL http://www.nidcd.nih.gov/funding/types/p50/staff.html

2. Peer Review Contacts:

Melissa J. Stick, Ph.D., M.P.H.
Chief, Scientific Review Branch
NIDCD/NIH
6120 Executive Blvd., Room 400C
Bethesda, MD 20892-7180
(For Express Mail/Courier please use
Rockville, MD  20852
Telephone: (301)-496-8683
FAX:  (301)-402-6250
Emil: stickm@nidcd.nih.gov

3. Financial or Grants Management Contacts:

Christopher Myers
Chief, Grants Management Branch
Division of Extramural Activities, NIDCD
6120 Executive Blvd., EPS 400-C, MSC 7180
Bethesda, MD 20892-7180
Telephone:  (301)-435-0713
FAX: (301)-402-1758
Email:  myersc@nidcd.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html), investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


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