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: Pediatric Critical Care Scientist Development Program [PCCSDP] (K12)

Announcement Type
This is a reissue of RFA-HD- 03-015, which was previously released May 28, 2003.

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

Request for Applications (RFA) Number: RFA-HD-08-022

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: July 3, 2008
Letters of Intent Receipt Date: October 20, 2008
Application Receipt Date: November 19, 2008
Peer Review Date: January/February 2009
Council Review Date(s): May 2009
Earliest Anticipated Start Date: July 1, 2009
Additional Information to Be Available Date (Url Activation Date): Not applicable
Expiration Date: November 20, 2008

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 Career Objectives

Section II. Award Information
1. Mechanism(s) 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, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
    D Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

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 Career Objectives  

Purpose

The purpose of this funding opportunity announcement (FOA) is to solicit applications for the Pediatric Critical Care Scientist Development Program (PCCSDP). The goals of the PCCSDP are to expand the cadre of investigators trained to advance research in pediatric critical care and to support educational institutions in their ability to stimulate novel research and innovative investigation into the scientific basis of pediatric critical care practice and the consequences of critical illness and injury for families and children.  The program will fund, up to a maximum of 5 years, the administration and infrastructure of one K12 Career Development Program.

Background

Several convergent developments in critical care medicine, as well as in the larger medical, scientific, and national communities, were fundamental to the initial NICHD decision to develop and maintain special support of pediatric critical care career development and research at the junior faculty level.  While clinical expertise in this rapidly evolving specialty is in short supply, the demand for intensivists to supervise the care of critically ill and injured children is growing. As the clinical, educational, and administrative agenda increases in complexity in critical care, time for fully trained pediatric intensivists to devote to research is decreasing.

The introduction of a number of principles of management and innovative methodologies without the rigorous controlled observation necessary for their objective evaluation presents a number of concerns.  A major problem has been the balance between assuring prompt implementation of new technologies, procedures, treatments, and drugs, and evaluation of their safety, efficacy, and cost/risk/benefit ratios.  In a critically ill or injured child, for example, an innovative idea may be tried, which, if the patient's condition improves, may rapidly start a new trend and become the standard of care, expected and demanded by families of such children and the professionals caring for them.  As a result, incorporation into the arsenal of critical care therapies may be based on limited experience, and efficacy and/or safety incompletely evaluated The use of the scientific method may be compromised by the pressured operational clinical milieu that surrounds pediatric critical care practice.

In addition, careful descriptive studies of the pathophysiology of the consequences of critical illness and injury in children as related to intermediate and long-term outcomes remain minimal; more is urgently needed.   Research into the mechanisms of tissue injury and organ failure in children would be of great benefit for children with complex illnesses, injuries and disability.  Very little is understood about how the developmental trajectory might affect or be affected by trauma, sepsis and organ failure.  The effect on families, siblings, communities and schools of the increasing population of disabled survivors of childhood critical illness and injury also remains understudied.

The first NICHD Pediatric Critical Care Scientist Development Program (PCCSDP) competition was held in 2003, and resulted in the successful establishment of a national K12 career development program.  The original RFA called for creation and direction of a K12 Career Development Program of national scope, providing mentored support for junior faculty in departments of pediatric critical care medicine in the USA.  This program was to prepare a cohort of researchers in pediatric critical care medicine, administered by a Program Director outside of the NICHD, with the goal of generating scientists who would be able to obtain independent support to conduct research in this urgently needed area.  The PCCSDP has succeeded in developing an operational administrative and scientific consortium for the counseling, selection and education of national pediatric intensivist junior faculty K12 applicants utilizing a National Advisory Committee of accomplished pediatric scientists.  The NICHD provides only consultative and supportive advice to the Program Director, ensuring that NIH priorities and policies are followed.

Objectives and Scope

It is expected that the scholars supported by this program will emphasize basic, clinical and translational research focused on intermediate and longer-term outcomes for children and families, especially related to reduction in morbidity and disability.  Recent discoveries across a broad range of basic and clinical science research areas have greatly expanded the options for the critically ill and injured child.  Advances in understanding of the molecular biology underlying organ system failure offer the possibility of manipulating otherwise poorly controlled processes, including inflammation, cell and organ injury, dysfunction and death, regeneration of tissues, and functional organ system capacity. 

Modalities of mechanical ventilation, non-invasive ventilation, circulatory support, and extracorporeal life support have extended therapeutic options to patients previously beyond the reach of state-of-the-art therapy.  The use of less invasive techniques in neurosurgery, general, and vascular surgery, as well as implementation of newer techniques of respiratory and circulatory support have been central to the radical changes in mortality recently achieved with cutting-edge pediatric critical care medicine.   As a result, children in higher risk groups who are victims of critical illness or injury, and those who might benefit from surgical interventions once not feasible, are benefiting from increased critical care options in increasing numbers.

Children with complex illnesses, combinations of medical, surgical, and traumatic processes, are surviving to discharge from multidisciplinary pediatric critical care units more frequently than before.  As mortality from critical illness and injury declines, survival of patients with disabling residuals of the critical pathology increases, and chronic medical conditions become more common in childhood.  In children, it is well known that such conditions make the risk of subsequent critical illness greater than in their age-peers.

Relatively few studies are available that might quantitate this risk and the impact of the increasing numbers of medically fragile children on families, schools, pediatric practices, and health care costs.  Measuring the efficacy of critical care practice by mortality, while essential in the early years of the specialty, is presently not practical.   Basic and translational critical care researchers can no longer afford to seek cell or tissue survival as an outcome independent of functional capacity and the implications for morbidity and disability.  Clinical researchers cannot effectively plan to use mortality as an outcome measure because contemporary pediatric critical care medical and surgical practice has ensured that mortality rates are uniformly low.  Certain diagnostic groups ( i.e., critical illness and organ failure in pediatric malignancy and head trauma) continue to have mortality rates that are substantial, although overall mortality has plummeted as pediatric critical care practice has evolved over the last two decades.

Support of pediatric critical care research must depend on basic and clinical science designed by intensivists in order to form the foundation of pediatric critical care practice.  There are few human laboratories in which tissue and organ function, pharmacologic kinetics, immune dysfunction, cell signaling and changes over time in humans can be studied, especially in the young.  Contemporary tertiary pediatric critical care units (PICUs) present unique scientific opportunities for the evolution of the science needed. The subspecialty has evolved rapidly in the clinical arena as described above, and the clinical services and leadership provided are in great demand.

About one half (45-55 percent) of emergency admissions to PICUs occur in children with known special needs.  When one considers, in addition, the admission of children for postoperative critical care following elective surgical procedures, the percentage of children in pediatric intensive care units with special needs is much higher. In addition, a large percentage of the cohort of previously healthy children admitted to pediatric critical care units will have special health care needs upon discharge.  Thus, focus on family effects, restoration of organ system function, and stress adaptation in basic, clinical and translational research is urgently needed.

Programs responsive to this solicitation should consider plans for the following: 

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 will use the Institutional Research and Academic Career Development Award (K12) grant award mechanism(s).

The Project Director/Principal Investigator (PD/PI) 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

The estimated amount of funds available for support of one award which may be made annually to a project awarded as a result of this announcement is $800,000 in direct costs for fiscal year 2009 Future year amounts will depend on annual appropriations.

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 and the receipt of a sufficient number of meritorious applications.

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

Applicants may not submit a resubmission application, as this is a one-time FOA.

Renewal applications will be permitted for this FOA.

Applicants may not submit more than one application,

Special Requirements

Components of the K12 Pediatric Critical Care Scientist Development (PCCSDP) Award

The K12 award provides five years of funding to the applicant organization to support a national career development and training program.  The Program Director, in consultation with the Advisory Committee, shall define the application process, review candidates, make appointments to qualified individuals, and monitor progress.

For each candidate, the four- to five-year career development program consists of two phases.  In Phase I, the candidate receives two to three years of intense career development training in a basic or clinical science discipline with an established mentor scientist at the mentor's institution. 

In conjunction with the mentor, the candidate develops a research and career development plan, which will be reviewed annually by the PCCSD program director and advisory committee.  Phase II begins with the transition to independent investigator status.  The PCCSD program will assist with placement in a sponsoring PCCM (or related) department, and continue to monitor progress and provide support as necessary. 

During Phase II (generally two to three years), individuals should be supported by independent research grants, departmental funds, and possibly even clinical duties - but not directly from the K12 grant.  It is expected that the PCCM departments associated with this PCCSD program will make a strong commitment to supporting individuals as they reach Phase II, including faculty positions and the provision of protected research time.

Principal Investigator/Program Director and Administrative Staff

The Program Director has responsibility for the day-to-day administration of the PCCSD program, and may receive up to 10 percent support from the K12 grant. The  Principal Investigator/Program Director must be a physician and senior faculty member who is knowledgeable about pediatric critical care research, has a record of success in laboratory and/or clinical investigation, and demonstrated skill in career development.

The Principal Investigator/Program Director may be assisted by a grant-supported part-time administrative assistant (up to 10 percent time and effort on the part of the administrative assistant).  In addition, limited funds may be provided for a well-qualified recruitment officer (up to 10 percent time and effort) to enhance participation in the program by women, members of minority groups that are underrepresented in biomedical research, and individuals with disabilities. 

Advisory Committee

The Advisory Committee, chaired by the Principal Investigator/Program Director, is a select group of scientists and clinicians who have interests and expertise in pediatric critical care research.  They also may be potential PCCSDP mentors. The Advisory Committee evaluates all applicants to the program, monitors progress of current scholars, and provides direct feedback to individuals as appropriate.

Mentors

Mentors shall be tenured faculty (or their equivalent) who have an established record of research productivity and grant support in areas of basic and translational research relevant to pediatric critical care medicine.  Generally, they will be researchers and clinicians from pediatric critical care and allied fields, whose particular expertise is needed to support certain career research goals.  Linkages to other departments should be encouraged, as they enhance the power of this career development program and pediatric critical care and rehabilitation research, in general.  Although mentors must demonstrate a commitment to the PCCSD program and potential scholars, they cannot receive salary, fringe benefits, or research support for this role from the K12 grant.

However, provisions are made to support the research activities of particular PCCSD scholars within their laboratories, as described below.  Mentors may be added to the roster of the program as appropriate, with NICHD approval.

It is expected that institutions that support PCCSDP scholars in Phase I make a strong commitment to supporting these candidates in Phase II when they seek positions as independent investigators, and that the Program Director seek and receive such assurance in writing before funding for the support of any scholar is provided.

PCCSDP Candidates

As part of its recruitment efforts, the PCCSD program should make every effort to broadly advertise career development opportunities and provide information on prospective mentors.  The program is required to seek out qualified women, individuals from underrepresented minorities, and persons with physical disabilities. 

PCCSD candidates should be physicians who have completed clinical training and are no more than five years beyond fellowship training when they enter the program.  An individual who has previously served as Principal Investigator of an NIH research grant (R01, R03, R21, P01), mentored career development award (K series), subproject of program project (P01) or contract (N01) may not be considered for career development training in this program. 

Candidates must be U.S. citizens or non-citizen nationals lawfully admitted for permanent residence and possessing an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident.  Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S.  They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration.  Individuals on temporary or student visas are not eligible.

Prospective scholars should be encouraged to contact potential mentors prior to formally applying to the PCCSD program.  Although remaining at the institution of their fellowship is a possibility for scholars under this award, academic diversity through research career development and clinical practice at a different institution should be strongly encouraged.

Wherever and however possible, the program should support career development in those areas of research that would have the greatest potential for a positive effect on the emerging field of pediatric critical care medicine, and benefit the growing population of children surviving critical illness and injury. 

Candidates must make a commitment to the PCCSD program for four to five years, spanning both Phase I and Phase II career development.  Upon entering the program, scholars should develop, in conjunction with their primary mentor, a long-range research and career development plan.  During Phase I, at least 75 percent of the scholar's time must be devoted to basic, translational or clinical research activities supported by the PCCSD program.  Provided they are making appropriate progress as judged by the Advisory Committee, scholars may be renewed annually for a maximum of three years of total Phase I support.  In the beginning of the second year, scholars should be strongly encouraged to seek outside grant support as they transition to independent researcher positions in their sponsoring PCCM departments and institutions.

Phase II scholars will remain associated with the PCCSD program for another two to three years, submit yearly progress reports, and attend PCCSD meetings.  However, they should develop independent and stable means of research support outside the K12 grant.  It is expected that their departments provide at least 50 percent - and preferably 75 percent - protected time for research activities during this period.  Total career development support under the PCCSD program may not exceed five years.  

During Phase I or II, scholars may engage in brief research activities at another institution if it is directly related to the purpose of the award.  Periods of leave from the program for greater than two months, whether for professional or personal reasons, require prior written approval from NICHD.  As well, any awardee permanently withdrawing from the PCCSDP after any  period of active support will be asked to submit a summary of the events leading up to that decision, and how she/he will or will not incorporate research into career development. 

In carrying out its stewardship of human resource-related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program.  Accordingly, awardee institutions are hereby notified that PCCSD scholars may be contacted after the completion of their career development experiences for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Recruitment Plan

Applicants should include a plan describing selection procedures for recruiting scholars. These plans should include recruiting efforts to enhance diversity. Applicants are encouraged to design a program that is appropriate for their pool of potential scholars and participating faculty/mentors.

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 most 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.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: October 20, 2008
Application Receipt Date: November 19, 2008
Peer Review Date: January/February 2009
Council Review Date(s): May 2009
Earliest Anticipated Start Date: July 1, 2009

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 by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Carol Nicholson, M.D., M.S.
Pediatric Critical Care and Rehabilitation Research Program
Eunice Kennedy Shriver National Institute of
Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 435-6843
Fax:  (301) 402-0832
Email: nicholca@mail.nih.gov 

3.B. Sending an Application to the NIH

Applications must be prepared using the 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 material must be sent to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of
Child Health and Human Development (NICHD)
6100 Executive Boulevard, 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1485
Email: stretchr@mail.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive 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 review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Special Budgetary Requirements

A composite budget and individual budgets for the Administrative Core and the total scholar costs should be provided. 

Administrative Core: The Administrative Core may include salaries and support for a Principal Investigator/Program Director (up to 10 percent time and effort), a part-time administrative assistant, and a recruiting officer (up to 10 percent time and effort).  It may also include funds for services specific to the administration of this program and not typically covered by institutional overhead charges (e.g., supplies, duplicating equipment, telephone, or maintenance contracts for equipment).  Travel of Principal Investigator/Program Director to annual PCCSD meetings may also be included.  The Administrative Core may include modest non-salary expenses for members of the Advisory Committee.

Scholar Expenses:  As indicated above, funds for prospective scholars should be provided on a separate budget, with indication of the number of positions requested and to what extent these funds will be used for salaries. Individual scholars are eligible for up to $75,000 per year in salary, in addition to fringe benefits, consistent with their institution's salary scale; this may not be supplemented with other Federal funds unless specifically authorized by that Federal program.  The total salary requested must be based on a full-time, 12-month staff appointment and requires scholars   to devote a minimum of 75 percent of full-time professional effort to conducting career development and health-related research with the remaining effort being devoted to activities related to the development of a successful research career.  For information regarding NIH policy on determining full-time professional effort for career awards, see: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html

For each scholar, up to $10,000 in additional funds may be budgeted each year to defray the costs of materials, supplies, technical assistance, and miscellaneous expenses generated by the scholar's research in the departments and laboratories of the established investigators who serve as mentors.  In specific cases, grant funds may also be used for tuition, fees, and books related to career development.  Up to $3,500 per scholar in travel funds may be budgeted to attend annual PCCSD functions and other professional meetings.  Total awards to individual scholars need not be equal across these different budget categories.  Salary and research expenses are not appropriate for Phase II scholars; however, the K12 grant may provide travel funds to allow them to attend annual PCCSD meetings at the discretion of the Principal Investigatory/Program Director, and with NICHD concurrence.

Facilities and administrative costs on K12 awards are limited to eight percent of modified total direct costs.

Items that may NOT be supported with K12 grant funds include:

The application should include a detailed budget for the initial budget period, and a composite budget for the entire proposed period of support and appropriate justifications in narrative form.  As described above, the administrative core may include Personnel, Supplies, Travel Expenses (for the Principal Investigator and Program Director to annual PCCSD meetings), and Other Expenses.  Funds for prospective scholars should be listed on a separate budget page with indication of the number of positions.  Facilities and administrative costs on K12 awards are limited to eight percent of modified total direct costs (less tuition, fees, and equipment). 

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 and Information

Biographical Sketches

A biographical sketch is required for all key personnel to assess each individual's qualifications for their specific role in the program, as well as to evaluate the overall qualifications of the career development network.  Include information on current research projects and those completed during the last three years.  For Advisory Board nominees, include a brief justification for their role in the PCCSD program.  For proposed mentors, provide a paragraph on the relevance of their research to pediatric critical care medicine.  No more than four pages may be used for each person.

Research Plan Page Limitations

Not applicable

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 of the Research Plan component. 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: 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

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD 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 following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

Innovation:  Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?   

Investigators: Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment:  Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? 

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed career development program. The priority score should not be affected by the evaluation of the budget.

Training in the Responsible Conduct of Research: Does the proposal include a plan for every candidate to receive formal instruction in the responsible conduct of research? Are the plans adequate to insure adequate instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human subjects, tissues and other specimens? Have sufficient discussion of the relationship and the specific responsibilities of the institution and the Scholar candidates appointed to the program been planned. Do plans address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, candidate attendance, and the frequency of instruction? Have they provided an adequate rationale for the proposed plan of instruction? If it is a competing continuation, is there a report showing good progress in training in the responsible conduct of research per: the type of instruction provided, topics covered, and other relevant information, such as attendance by Scholar candidates and faculty participation?

2.C. Resource Sharing Plan(s)   

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

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.

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 (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the business official.

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.

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

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:

Carol Nicholson, M.D., M.S.
Pediatric Critical Care and Rehabilitation Research Program
Eunice Kennedy Shriver National Institute of
Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 435-6843
FAX:  (301) 402-0832
Email: nicholca@mail.nih.gov 

2. Peer Review Contacts:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of
Child Health and Human Development (NICHD)
6100 Executive Boulevard, 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1485
Email: stretchr@mail.nih.gov

3. Financial or Grants Management Contacts:

Bryan Clark, MBA
Chief Grants Management Officer 
Grants Management Branch
Eunice Kennedy Shriver National Institute of
Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 8A01C, MSC 7510
Rockville, MD 20852 (for express/courier service)
Bethesda, MD 20892-7510
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. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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/

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.

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.

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-02-005.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. Applications that do not provide this information will be returned without review.

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 or Health Systems Agency review. 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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