Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov)

Title:  NICHD Program Project Grant (P01)

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, seehttp://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-10-245

Catalog of Federal Domestic Assistance Number(s)
93.865  

Key Dates
Release Date: August 3, 2010
Letters of Intent Receipt Date(s): Not applicable
Application Submission Dates(s): Standard dates apply; please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Dates(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date: Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: (Now Expired July 2, 2013 per issuance of PAR-13-257), Originally September 8, 2013

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
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

Purpose

This funding opportunity announcement (FOA) issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) encourages innovative, multidisciplinary, interactive, and synergistic program project (P01) grant applications to support research on reproductive, developmental, behavioral, social, and rehabilitative processes that determine the health or functioning of newborns, infants, children, adults, families, and populations.

The purpose of the P01 mechanism is to encourage investigation of complex problems relevant to NlCHD's mission and to facilitate economy of effort, space, and equipment. Under appropriate circumstances, the collaborative research effort of a program project can accelerate the acquisition of knowledge more effectively than a simple aggregate of research projects without thematic integration.

Background

The program project grant is an institutional award for the support of a research program that has a well-defined central theme, research focus, or objective. P01s must have at least three interrelated Research Projects along with the Core resources necessary to support these projects.  The  interrelationships and synergism among component Research Projects will often be multidisciplinary in nature, and should result in greater scientific contributions than if each subproject were supported individually. The P01 is based on the concept that projects closely related to a central theme can be conducted more effectively and efficiently through a coordinated, collaborative, multidisciplinary approach.

The P01 research effort is facilitated by the sharing of ideas, data, and specialized resources, such as equipment, services, and clinical facilities. Although the Research Project components must be scientifically meritorious, they also must complement one another, be interdependent, and support the program's overall theme. Thus, the program's overall scientific merit should be greater than the sum of its parts.

Component Research Projects should be led by experienced scientists with a variety of disciplinary and specialty backgrounds. They should be able to collaborate productively so that new scientific information may be freely exchanged and effectively applied by others in the program. The Program Director/Principal Investigator (PD/PI) of the overall P01 should be an established with demonstrated administrative capabilities.

Regular meetings of participating investigators who share and evaluate results and new ideas are essential to the consolidation of the Research Projects into a cohesive program.  The participating investigators are expected to assist the PD/PI in making administrative as well as scientific decisions.  The judicious use of an external advisory committee, composed of consultants from outside the program, can be helpful in providing independent program evaluation and guidance. Applicants are encouraged to consider incorporating these methods of communication/coordination in their programs.

Essential Features of a Program Project:  

The program project size should be planned carefully.   The program must comprise a sufficient number of scientifically meritorious R01-type Research Projects (at least three) to permit an effective collaborative effort among the participating investigators. On the other hand, research efforts should not be so diverse and diffuse in scope as to hinder productive collaboration. In such instances, consideration should be given to submitting individual R01 research project grant applications. P01s that are too large may inhibit communication and interaction among collaborators and, as a result, become less effective.

Research Scope

The NICHD invites P01 applications in any research area relevant to the mission of the Institute as represented by its program areas.  The research interests of NICHD are described in more detail at: http://www.nichd.nih.gov/research/org/supported_by.cfm

Developmental Biology and Perinatal Medicine:   Complex biological processes, which determine health and well-being later in life, begin even before conception.  Fetal and early childhood development set the stage for physical, cognitive, and behavioral outcomes. A major NICHD priority is to advance fundamental and clinical knowledge about maternal health and problems of child development. This research includes (but is not limited to):

Maternal and Child Health:   A major priority of the NICHD is to conduct research to improve maternal and child health in the United States and worldwide. This research includes (but is not limited to):

Contraception, Reproduction, and Population Research:  Understanding reproductive health and biology for both men and women is crucial to improving health and quality-of-life around the world. Improved knowledge about human population dynamics is also essential to successful and sustainable communities. This research includes (but is not limited to):

Medical Rehabilitation Research:  Medical rehabilitation research is essential to developing scientific and technical knowledge needed to enhance health, productivity, independence, and quality-of-life for people with disabilities. This research includes (but is not limited to): 

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 Program Project (P01)  award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.  

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

Funding caps for P01 grants are as follows:

For new applications, the first-year cap is $750,000 direct costs, with a cumulative cap of $4,000,000 direct costs over a 5-year period.  For competing continuation applications, the first-year direct cost maximum is either $750,000 or an amount 10% above the direct costs awarded in the last non-competing year, whichever is greater.  In addition, there is a cumulative cap of $5,000,000 in direct costs over a 5-year award period.  For the purpose of funding caps, the calculation of total direct costs may exclude all facilities and administrative (indirect) costs, including those indirect costs associated with subcontracts.

In addition, all P01 applications must follow the requirements of the NICHD Large Grant Policy as described at http://www.nichd.nih.gov/funding/policies/large_grants.cfm.  For the case of P01 applications, "large grants" are defined as those requesting $750,000 or more in direct costs in any year.  This policy applies to all large grant applications, including new, competing continuation, supplemental, and amended applications.  A request for waiver of this policy must be submitted by Program Staff for consideration by the NICHD Office of Extramural Policy (OEP), even if such a request has been approved for a previous submission.  Applicants who wish to submit a “large grant” under this policy must make their request no later than 6 weeks prior to the application receipt date.

Rules for allowable costs are set forth in the NIH Grants Policy Statement and in the NIH Guide for Grants and Contracts, unless otherwise stated in the Notice of Award. Under these guidelines, the PD may exercise flexibility to meet unexpected requirements by rebudgeting or requesting approval to rebudget among budget categories within the total cost of a project (as shown on the Notice of Award).

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.

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided that each application is 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 competing renewal applications are permitted only a single amendment (A1).  See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing 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.

Section IV. Application and Submission Information


1. Address to Request Application Information

The current 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

Prepare all applications using the PHS 398 application forms in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html). 

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.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): Not applicable
Application Submission Dates(s): Standard dates apply; please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Dates(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date: Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

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, 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)

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 and all copies of the appendix materials must be sent to:

Sherry L. Dupere, Ph.D.
Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD 20852 (for express/courier service; non-UPS service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email:  duperes@mail.nih.gov

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

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/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements

NICHD Program Project (P01) Grant Applications

Applications must be submitted on Grant Application Form PHS-398 (http://grants.nih.gov/grants/funding/phs398/phs398.html). 

The PHS 398 Application Instructions http://grants.nih.gov/grants/funding/phs398/phs398.html) are to be followed, with the following additional requirements.

Page Limits

For New P01 applications, page limits are as follows:

For Resubmission or Revision applications, also include the following: 

Format of the PHS 398 application

The following guidelines provide directions for preparing each section of the application.  The Table of Contents described for PHS-398 Form Page 3 should contain the headings outlined below in Section l —Preliminary Pages and Section ll – Research Plan.   The Table of Contents should be paginated to enable reviewers to readily find specific information.   

SECTION I:  PRELIMINARY PAGES

  1. Face Page (Form Page 1)

Complete all items on the application's face page.  For Item 2, enter the number of this FOA and the title, "NICHD Program Project Grant (P01)”.  Number succeeding pages consecutively.

  1. Description: Project Summary and Relevance, Project/Performance Site(s), Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (Form Page 2 and 2-continued)

Describe briefly the proposed research program, indicate the research emphasis of the component Research Projects, and identify the purpose of the proposed Core units.

List all Senior/Key personnel and Other Significant Contributors engaged on the project.  Use continuation pages as necessary, numbering consecutively.

  1. Table of Contents (Form Page 3)

Prepare the Table of Contents including the major headings as noted above.

  1. Budget Instructions (Form Page 4):   

Prepare a series of composite budget tables for the P01 grant as requested below, followed by a detailed budget for each Research Project component and each Core unit.

A.    Composite Budget

Use PHS-398 Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD,"  to present the total budget for all requested support for the first year. For each category, such as "Personnel," "Equipment," etc., give the amount requested for each Research Project component and each Core unit, with subtotals.

If consortium arrangements involving other institutions or organizations are anticipated, include total (direct and indirect) costs associated with such third-party participation in the Consortium/Contractual Costs category. Costs for purchased services should be itemized under the "Other Expenses" category.

Use PHS-398 Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," to prepare a budget, by category, that provides totals for each year of requested support. Requests for any increases in succeeding years must be justified in the individual Research Project component and Core unit budgets.

B.    Budgets for Individual Research Project Component and Core Component  

Budget Justifications and Explanations: Describe the specific functions of all key personnel, consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For additional years of support requested, justify any significant increases or decreases in any category over the first 12-month budget period. Identify such changes with asterisks against the appropriate amounts. If a recurring annual increase in personnel or other costs is anticipated, give the percentage; however, current NIH practice limits escalation to 3%. In addition, for COMPETING CONTINUATION applications, justify any significant increases in any category over the current level of support.

PLEASE NOTE: Consortium budgets (if applicable) should be presented as described in A, including budget for the entire proposed project period. Total direct and indirect costs of sub-awardee are to be shown under Consortium/Contractual costs on the individual component budget and a detailed sub-awardee budget is to be placed following the appropriate Research Project or Core budget.

5.     Biographical Sketch (Biographical Sketch Format Page):

Follow the instructions on the Biographical Sketch Format Page. This section must contain the biographical sketches of all individuals listed as Senior/Key Personnel and Other Significant Contributors, following the order listed on Form Page 2.  Biographical sketches are required for all key personnel participating in the Research Project components and Core units.   Begin with the P01 overall PD/PI  and thereafter, in alphabetical order, submit biographical sketches as described in the Instructions for Form PHS-398. Do not exceed four pages for each person.

6.     Resources (Resources Format Page):

Complete the "Resources" page of PHS-398 for the overall project. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources.

SECTION II - RESEARCH PLAN

Include a detailed Table of Contents with pagination (numeric only) at the beginning of Section II.

Identify each Research Project component and each Core unit by title. Assign each Research Project component a Roman numeral (I, II, III) and assign each Core unit a capital letter (A, B, C) that reflects the order in which they are presented.

For each Research Project component and Core unit, provide the name of the responsible investigator, and biographical sketches for personnel not identified previously.

  1. Overview of the Program Project (12 pages)

A.    History and Purpose of the Program

Discuss the overall P01 program's objectives and general plans for the proposed grant period, including research grant history with yearly funding level.

B.    Administration, Organization, and Operation

Include information on the support and commitment of the parent institution for the program, the authority of the PD/PI, the use of advisory committees, and space assignment. Describe organizational framework and provide an organizational chart.

C.    Research Program

Discuss the proposed research program, highlighting its central theme. List by title and investigator's name the component Research Projects and Core units.  Describe  the relationship between the projects and the Core units and their relationship to the central theme.

D.    Description of Assurances and Collaborative Agreements

Provide an overview and rationale for any collaborative and cooperative endeavors or subcontracts.  Letters of agreement for these arrangements are included in Item 6. Letters of Assurance/agreement as described below.

  1. Research Project Descriptions  (12 pages for each Research Strategy component)

Identify each project by a Roman numeral (I, II, III...) and a title.

A full description of each project is to be provided following the format and instructions for Form PHS-398 (http://grants.nih.gov/grants/funding/phs398/phs398.html).

Begin the presentation of each Research Project component on a separate page, and include the following: 

A.    Research Project Cover Page (1 page)

B.    Abstract of Research Plan (1 page;  use PHS-398 Form Page 2):   Discuss the purpose and nature of the project and its relevance to the program's overall theme.
 

C.    Content of Research Plan (Begin each section with a section header)

    1. Introduction to Application (resubmission or revision applications only)
    2. Specific Aims (1 page)
    3. Research Strategy (12 pages;  Significance, Innovation, and Approach):   Start each section with the appropriate section heading—Significance, Innovation, Approach. Cite published experimental details in the Research Strategy section and provide the full reference in the Bibliography and References Cited section.

For new applications, include information on Preliminary Studies.

For renewal/revision applications, provide a Progress Report.

Indicate the Research Project's use of Core unit services, including why needed and the advantages and cost effectiveness of Core unit usage for the project.

    1. Inclusion Enrollment Report (renewal or revision applications only)
    2. Bibliography and References Cited, Progress Report Publication List
    3. Protection of Human Subjects
    4. Inclusion of Women and Minorities
    5. Targeted/planned Enrollment Table
    6. Inclusion of Children
    7. Vertebrate Animals
    8. Select Agent Research  
    9. Investigators  
    10. Consortium/contractual arrangements
    11. Letters of Support:  Include pertinent letters of assurance and collaboration for the Research Project.  For off-site projects, justification should be provided for the project's location, and plans for interaction and cooperation with the other components of the program should be addressed.
    12. Resource Sharing Plan

3.     Core Unit Descriptions

Identify each proposed Core unit by a letter (A, B, C...) and a title (e.g., Administrative Core, Molecular/Cellular Core, etc.).  A full description of each Core unit is to be provided following the format presented in Form PHS-398.  Begin the presentation of each Core unit on a separate page.   Include the following:

A.    Core Unit Cover Page (1 page)

B.    Abstract (1 page;  use PHS-398 Form Page 2):   Include an Abstract that identifies and describes the purpose of the proposed Core unit.  Summarize the Core unit's overall objectives; highlight the decision-making process for use of Core services and plans for cost-effectiveness and quality control.

C.    Introduction (Resubmission or Revision Applications only;  1 page)

D.    Core unit Structure, Administration, and Services

E.    Use of Core Units by Research Project Components 

Provide a summary for the first year of the proposed grant showing the percentage use of each Core unit by the Research Project components. 

  1. Progress Report Publication List (for competing renewal applications only)

List publications prepared during current grant period (or the past five-year period) which report results of research supported by the grant.

  1. Letters of Assurance/Agreement  

Any arrangements for collaborative and cooperative endeavors or subcontracts should be highlighted. Include letters of agreement from consultants. For projects to be conducted off site, i.e., at an institution other than the applicant institution, a PHS-398 face page or other documentation, signed by the off-site institutional officials, must be submitted with the application.

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

Specific Instructions for P01 Applications Requesting $750,000 Direct Costs or More per Year

Applicants requesting $750,000 or more in direct costs for any year (excluding consortium F&A costs)  must carry out the following steps:

This policy applies to all new, renewal, revision, or resubmission applications. See NOT-OD-02-004.

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 should 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: Regardless of the amount requested, investigators 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 the NICHD 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. 

For NICHD program project (P01) applications, peer review of scientific and technical merit focuses on three areas: (1) review of the individual Research Project components; (2) review of the individual Core units; (3) review of the P01 program as an integrated collection of research projects and cores oriented around a central theme, and the overall merit of the program.

Review Criteria for Individual Research Project Components

The following standard review criteria will be used for the evaluation of the individual Research Project components: 

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 scored review criteria, and additional review criteria (as applicable for the project proposed). 

Scored 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? 

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

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 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?

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? 

Review Criteria for Core Unit Components

Reviewers will assign an impact/priority score based on the assessment of each Core unit independently in terms of the specified review criteria for Cores. Separate criterion scores will not be assigned for Cores.  The following review criteria will be used for the evaluation of the individual Core units. 

For all Cores, the review will evaluate the following:

For the Administrative Core, the review will also evaluate the following:

Review Criteria for Overall Program Project

The overall P01 program project application will be evaluated as an integrated research effort focused on a central theme.  The relationship and contributions of each Research Project and Core to the overall theme of the program project will be discussed and evaluated.  Reviewers will assign an impact/priority score based on assessment of the scientific and technical merit of the overall program project. The assessment will take into consideration all proposed Research Projects and Cores, including any with poor ratings.  Separate criterion scores for the overall program will not be assigned. 

The review will assess the level of merit of the program project as an integrated effort, including the following considerations:

Additional Review Criteria 

As applicable for the project proposed, 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.  For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

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.

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.

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.

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).

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.

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:

3. Anticipated Announcement and Award Dates

Not Applicable

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 Notice of Award 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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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:

Depending on the application's subject matter, communications should be directed to relevant program staff or one of the following individuals:

Gilman Grave, M.D.
Director, Center for Research for Mothers and Children (CRMC)
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Executive Building, Room 4B05
6100 Executive Boulevard, MSC 7510
Bethesda MD 20892-7510
Telephone: (301) 496-5097
E-mail: graveg@mail.nih.gov  

James Hanson, M.D.
Director, Center for Developmental Biology and Perinatal Medicine (CDBPM)
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Executive Building, Room 4A05
6100 Executive Boulevard, MSC 7510
Bethesda MD 20892-7510
Telephone: (301) 496-8535
E-mail: hansonj@exchange.nih.gov

Florence P. Hazeltine, M.D.
Director, Center for Population Research (CPR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Executive Building, Room 8B07
6100 Executive Boulevard, MSC 7510
Bethesda MD 20892-7510
Telephone: (301) 496-1101
E-mail: haseltif@exchange.nih.gov

Michael Weinrich, M.D.
Director, National Center for Medical Rehabilitation Research (NCMRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Executive Building, Room 2A03
6100 Executive Boulevard, MSC 7510
Bethesda MD 20892-7510
Telephone: (301) 402-4201
E-mail: weinricm@mail.nih.gov

2. Peer Review Contacts:

Sherry Dupere, Ph.D.
Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Blvd, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service;  non-USPS service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: duperes@mail.nih.gov

3. Financial or Grants Management Contacts:

Bryan S. Clark, MBA
Chief Grants Management Officer
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Blvd, Room 8A01A
Rockville, MD 20852
Telephone: (301) 435-6975
FAX: (301) 402-0915
Email: clarkb1@mail.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/archive/archive/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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