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: Child Health Research Career Development Award (CHRCDA) Program [K12]

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of RFA-HD-07-010.

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

Request for Applications (RFA) Number: RFA-HD-10-007

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF 424 Research and Related (R&R) forms and the SF 424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)

93.865

Key Dates
Release/Posted Date:  April 9, 2010
Opening Date: May 10, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): May 10, 2010
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date: June 9, 2010
Peer Review Date(s): July/August 2010 
Council Review Date(s): October 2010
Earliest Anticipated Start Date(s): December 1, 2010
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration/Closing Date: June10, 2010

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. Institutional Research Career Development Program 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. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review, and Anticipated Start Dates
          1. Letter of Intent
    B. Submitting 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. Institutional Career Development Program Objectives

Purpose

This funding opportunity announcement (FOA) issued by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, is to provide junior faculty with state of the art training in an academic research setting to stimulate pediatric research over a variety of disciplines.  The program provides supervised research training to assist junior faculty in their transition into productive, physician scientists in areas related to pediatrics and its subspecialties.

The goal of the Child Health Research Career Development Award Program is to promote the performance of research and transfer of findings that will benefit the health of children. This will be accomplished by supporting research career development of Pediatricians, to be known as CHRCDA Scholars. These K12 Program grant awards will ultimately result in a well-qualified cadre of academic pediatrician scientists who will help strengthen the research capacity and meet the need for highly skilled scientists with a clinical background who can address the increasing research opportunities in pediatrics.

Background

The CHRCDA program was initiated by NICHD in 1990 in response to concerns about the need for greater numbers of physician scientists in pediatric research. The CHRCDA Program supports research career development of pediatricians who have recently completed postgraduate clinical training, and who are commencing basic or translational research relevant to the field of pediatrics.  This funding opportunity is intended to address the need for basic science training at the postdoctoral level and provide a transition to independence. Senior investigators with established research programs covering a broad range of basic and applied biomedical science related to pediatrics, together with collaborating departments, form the intellectual and technical base for mentoring CHRCDA scholars. Although mentors from collaborating departments may provide needed expertise and resources, the emphasis should be on research ultimately relevant to pediatrics, and its subspecialties. There is expectation that the K12 Programs established in response to this announcement will provide the ideal environment for development of independent researchers able to sustain viable careers and mentor those that follow them.

Types of Research and Experimental Approaches

The research scope encompasses all areas of pediatrics and its related subspecialties. Projects should be basic science or translational and must be within the biomedical purview of the NIH. Scholars with minimal past research experience may devote the initial months of their program to didactics such as courses in proteomics, genomics,  molecular biology techniques, newest options for DNA sequencing, and tools to analyze and manage the data.

The NIH encourages all proposed programs to foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals from disadvantaged backgrounds, individuals with disabilities, and women.

Organization

Principal Investigator (PI/PD) The PI/PD must be a Chairperson of a Department of Pediatrics of an eligible institution. He/she should possess the scientific background, leadership, and administrative capabilities required to coordinate and supervise an interdisciplinary research and development program of this scope.  Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Training Director (TD) -- The TD must be an experienced investigator with responsibility for the day-to-day operations of the Program.  The experience and qualifications of the TD should complement those of the PD/PI, and the division of responsibility between the two individuals should be described clearly in the application. If appropriate, the PI/PD may serve a dual role as both the PI/PD and the TD.

K12 Scholars – Candidates for appointment to the K12 program are junior-level faculty who have recently completed postgraduate clinical training in Pediatrics, and are committed to launching an independent research career. The program provides supervised research training to assist these faculty as they transition into productive, physician scientists in areas related to pediatrics and its subspecialties. 

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

Section II. Award Information


1. Mechanism of Support

This FOA will use the NIH Institutional Research Career Development (K12) award mechanism.  The PDs/PIs (if multiple PD/PI option is used) will be solely responsible for planning, directing, and executing the proposed institutional career development program. 

This FOA uses “just-in-time” information concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format.  Applicants must complete and submit detailed categorical budget requests using the SF24 Research and Related (R&R) Budget Component found in the application package for this FOA.

Institutional career development grant support is available for new or renewal (formerly “competing continuation”) applications.   It is recommended that applicants contact the scientific/research contact listed in Section VII concerning the submission of a renewal (formerly “competing continuation”) application.  Only one resubmission (formerly “revision/amendments”) of a previously reviewed grant application may be submitted.  See NOT-OD-09-003, NOT-OD-09-016.

2. Funds Available

Because the nature and scope of the proposed institutional career development program 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 NICHD provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The NICHD intends to award up to $2,400,000 in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2011 to fund up to six new and/or renewal (formally known as competing continuation application) grants in response to this funding announcement. An applicant may request a project period of up to five years and a budget for direct costs of up to $400,000 per year. Future year amounts will depend on annual appropriations. The awards will have an anticipated start date of December 1, 2010 and continue through November 30, 2015.

Facilities and Administrative (F&A) costs requested by consortium participants, if applicable, are not included in the direct cost limitation.  See NOT-OD-05-004.  

Allowable Costs

Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the institutional career development program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution.  Note that instructions for completing the budget information in the SF 424 (R&R) application, using the Research & Related (R&R) budget, are included in Section IV, “Selecting the Appropriate Budget Component.”

Personnel: Individuals designing, directing, and implementing the career development program may request salary and fringe benefits appropriate for the person months devoted to the program, subject to the restrictions indicated below.  Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. If mentoring interactions and other activities with scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds. Limited program-related administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified.  These expenses must be itemized in Sections A and B, as appropriate, of the R&R Budget.

Program Administration Costs:

Scholar Costs:

Scholars are those individuals who benefit from the proposed activities and experiences involved in the career development program. Scholar costs must be justified as specifically required for the proposed career development program and based on institutional policies for salaries paid to individuals in similar positions, regardless of the source of funds.   These expenses must be itemized in the SF424 R & R Section B (scholar salaries) and F (other program-related expenses) as appropriate.

Up to $400,000 direct costs annually may be requested for up to four Scholars in the Scholars’ Budget.  Smaller programs with fewer scholars and reduced budgets are welcome to apply.  As part of the Scholars Costs, an applicant can request up to four CHRCDA Scholar positions.  Awards to CHRCDA Scholars need not be equal in size. Up to $100,000 annually may be requested per Scholar to support salary, fringe benefits and research costs.

Salary: Scholars may be provided salary support up to $75,000 per year, which includes any fringe benefits charged according to grantee institutional policy.  Salaries must be consistent with the institution’s salary scale for equivalent positions.  The total salary requested must be based on a full-time, 12-month staff appointment and requires Scholars to devote a minimum of 9 person months (equivalent to 75 percent) of full-time professional effort toward health-related research and career development activities, 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.htmlThe institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the program.

Items that may NOT be supported with K12 funds include:

Facilities and Administrative (F&A) Costs: F&A costs for the applicant organization and consortium participants will be reimbursed at 8 percent of modified total direct costs (excluding tuition, fees, and equipment).  

NIH Grants Policy: NIH grants policies as described in the http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. (See Section VI.3. “Reporting.”)

2. Cost Sharing or Matching

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

3. Other - Special Eligibility Criteria

Sponsoring Institution: The sponsoring institution must assure support for the proposed institutional career development program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and relevant resources that can contribute to the planned program. Applicant institutions must also guarantee the required protected time for the scholars selected for support. The application must include a letter explaining the institutional commitment to the proposed institutional research career development program (see Section IV.6, item 14).

Scholars: Individuals to be supported by the institutional career development program must be at the career level for which the planned program is intended. Scholars are expected to devote a minimum of 9 person-months (75% of full-time professional effort) during the appointment on the K12 award.

An institution receiving a CHRCDA Program award must recruit and select Scholars who have the potential to develop into independent investigators. At the time of appointment to the K12 Program, candidates for CHRCDA Scholars must:

The Scholar position is a junior faculty appointment, not a fellowship or extension of a fellowship position. Completion of subspecialty training is not required. Those who subspecialize may be appointed to the K12 program in the final research year of subspecialty fellowship training, if the fellowship provides similar basic science training to this K12 program. That year would be counted as the initial part of the K12 experience, not an additional year in the K12 program.  This policy is described in the NIH Guide for Grants and Contracts on May 3, 2007 (http://grants.nih.gov/grants/guide/notice-files/NOT-HD-07-016.html). 

Some individuals who are interested in the K12 program may have had a career hiatus because of family responsibilities, uniformed service, or other circumstances.  For such individuals, the hiatus will not count against the 4-year limit specified above.  The PI/PD should discuss plans to appoint these candidates with NICHD staff.  New Scholar appointments may be made any time during the year.

During the period of this award, Scholars may not accept or hold any other PHS award that duplicates the provisions of this career award. However, Scholars may remain eligible for other individual mentored career development awards (e.g., K01, K08, K22, K23, K25, K99) at the conclusion of the K12 appointment if additional training is needed to establish research independence.  Combined support through the K12 and other mentored career development award programs must not exceed six years.   Scholars should contact NICHD staff if there are questions regarding eligibility.

Scholar Citizenship and Residency Requirement: Only U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who have a currently valid Permanent Resident Card (USCIS Form I-551), or some other verification of legal admission as a permanent resident prior to admission into the K12 program, are eligible for scholar support from this program.  Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S.  They are usually persons 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.

Mentors: Mentors will interact closely with the scholar, and should have research expertise and experience relevant to the proposed career development program. Mentors must be committed to continue their involvement throughout the total period of the scholar’s career development under this award.

Each Scholar appointed under the K12 award must be assigned one or two mentors based on the scholar’s research experience, intended project, and need for intensive supervision and support. The mentors should be recognized as independent investigators who are actively involved in basic or translational research and who have a successful record of providing research training of a type expected in this Program. The mentors should hold faculty positions, be supported by NIH or other competitively awarded grants, and be acknowledged experts in the application of new advances in basic science or translational research. The established investigators, as mentors, will make available their expertise, guidance, and laboratory facilities to be utilized by Scholars for research projects that will enhance their knowledge and skills. Mentors must have track records in mentoring and training, and must interact closely with the Scholar in order to develop a career development plan. Mentors are not required to be members of the Department of Pediatrics. Although mentors from collaborating departments may provide needed expertise and resources, the emphasis of the CHRCDA Scholars' scientific projects should be on research relevant to pediatrics and its subspecialties.

Number of Applications: Only one application per institution may be submitted.   

Resubmissions.  Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications from the previous issuances RFA-HD-07-010 are permitted in response to this FOA.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an applicationSeveral of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential.  Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number.  Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

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 SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) Cover component
SF424 (R&R) Project/Performance Site Locations Component
SF424 (R&R) Other Project Information Component
SF424 (R&R) Senior/Key Person Profile Component
SF424 (R&R) Budget Component
PHS398 Cover Page Supplement Component
PHS398 Research Training Program Plan Component (for Institutional Research Career Development Program)
PHS398 Checklist

Optional Components:
PHS398 Cover Letter Component
SF424 (R&R) Subaward Budget Attachment(s) Form

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Application Due, Review and Anticipated Start Dates
Opening Date: May 10, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): May 10, 2010
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date: June 9, 2010
Peer Review Date(s): July/August 2010 
Council Review Date(s): October 2010
Earliest Anticipated Start Date(s): December 1, 2010

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:

Karen Winer M.D.
Endocrinology, Nutrition, Growth Branch
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B11, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 for courier/non-USPS service
Telephone: (301) 435-6877
Fax: (301) 480-9791
Email: winerk@mail.nih.gov

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED.  All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

3.C. Application Processing

3.C.1. Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

All applications must meet the following criteria to be considered “on-time”:

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2. Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons.  The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays.  All errors must be corrected to successfully complete the submission process.  Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3. Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, application will be evaluated for completeness by the CSR and responsiveness by the IC.  Incomplete and/or non-responsive applications will not be reviewed.


There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

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.

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.

6. Other Submission Requirements

Applicant Institution

Applicant institutions should have a well-established record of success in developing independent investigators.  The sponsoring institution must show commitment to the K12 Program's goals, and provide assurances that the institution intends to support the Program and its Scholars. The sponsoring institution must be able to provide appropriate faculty to serve as mentors. Research facilities and training opportunities will be a critical part of the environment. Applicant institutions must provide a guarantee of 9 person months (equivalent to 75 percent) protected time for the K12 Scholars.  Applicant institutions should demonstrate a commitment to the recruitment and retention of underrepresented racial and ethnic minorities and individuals with disabilities.

Principal Investigator (PI/PD)

The PI/PD of a CHRCDA Program must be the Chair of the Department of Pediatrics or equivalent. He or she makes the final decisions regarding appropriate recipients of the program funds for research and career development, taking into consideration recommendations from the CHRCDA Advisory Committee. The PI/PD cannot receive salary or fringe benefit support from the CHRCDA Program for this activity.

Training Director (TD)

The TD will have responsibility for some or all of the day-to-day operations of the CHRCDA Program. The TD should be an established investigator with experience and qualifications complementing those of the PI/PD.  The TD should possess the scientific expertise, leadership, and administrative capabilities required to coordinate and supervise a program for mentoring junior investigators. The PI/PD as well as the TD should have a record of accomplishment in mentoring successful investigators.

Career Development Program 

The application must describe the institutional commitment to support the CHRCDA Program's goal of developing and retaining productive, independent investigators in areas of child health. Support for junior investigators is designed to enhance their research skills, thereby providing a bridge between formal research training and the receipt of independent research grants. Applicants must propose a career development program that will maximize the use of relevant research and educational resources to foster education, training, mentoring, and professional development of Scholars, including women and minorities, in biomedical careers. The CHRCDA Program must have a strong research base, comprising the research investigations of established scientists who will provide expertise, resources, and mentoring to the Scholars. The research base must be broad and relevant to current and future areas of pediatrics. The Program must have a scientifically sound and equitable procedure for recruiting and selecting Scholars and their research projects supported by the Program. The Principal Investigator, after considering recommendations from the Advisory Committee, will select junior faculty for CHRCDA Scholar appointments for the pursuit of research projects under the guidance and supervision of an established mentor. Mentors with basic science expertise are most valued.

The K12 award provides five years of funding. The program will support up to four Scholars for periods of approximately two to five years consisting of consecutive 12-month appointments. At least 9 person months (equivalent to 75 percent) of the Scholar's full-time professional effort must be devoted to the K12 program. The remainder of the recipient Scholar's time may be devoted to developing other academic pursuits consonant with the objectives of the award. The 75 percent minimum effort in this program is intended to be primarily devoted to research; however, Scholars may, as needed, receive formal didactic coursework to support their career development.  The program must include appropriate training in biomedical ethics and the responsible conduct of research.  Competing renewal grants are contingent on demonstration of good judgment, as indicated by the use of funding, scientific progress, success of the junior investigators in competing for new research grants and contracts, and the development of new pediatric physician scientists.

Support for Scholars should be provided through a minimum of two consecutive 12-month appointments, renewable in annual increments, for up to five years total. Support of Scholars is renewable at the discretion of the PI/PD, contingent upon presentation of evidence of satisfactory progress as determined by the Advisory Committee. The pool of potential Scholars and criteria for selecting CHRCDA Scholars must be described in the grant application. Institutions are encouraged to develop novel mechanisms for recruiting qualified pediatricians.  Such mechanisms should include special efforts to recruit individuals from underrepresented racial and ethnic groups, individuals from disadvantaged backgrounds, and individuals with disabilities.  

K12 Scholars are strongly encouraged to apply for independent research grant support (e.g., R01, R21, R03) during the award. K12 Scholars in the last two years of career award support may reduce effort on the career award to a minimum of 50% and hold concurrent support from their career award and a competing NIH research grant if they are recognized as a Principal Investigator or Subproject Director (see: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html). Independent NIH research grant support must conform to all NIH policies and guidelines as described in the NIH Guide for Grants and Contracts (NOT-OD-08-065).

Scholars may also be eligible for the NIH Extramural Loan Repayment Program (LRP) for pediatric investigators. More information about LRP can be found at http://www.lrp.nih.gov/

Scholars, as well as the PI/PD and TD, are expected to attend an annual CHRCDA Program meeting. One purpose of this meeting is to allow Scholars to present their career development award-supported research to their peers and the senior investigators at other programs. In addition, they will have an opportunity at these meetings to exchange ideas about common problems and make suggestions to NICHD staff about possible modifications in the program. Career development award-supported research reported in peer review journals or at scientific meetings must acknowledge the support received through the CHRCDA K12 Program.

Advisory Committee

The PI/PD must establish an Advisory Committee. The Advisory Committee will be a group of scientists from the sponsoring department, and other departments or institutions, as appropriate, with research interests relevant to the CHRCDA Program. The two major functions of the committee are to evaluate:  1) applications from potential Scholar candidates, and 2) the overall conduct of the Program. Specifically, the committee makes recommendations concerning Scholar appointments, evaluates ongoing research activities annually (including the interaction and integrated nature of the Scholars' research experience), and makes recommendations regarding their continuation. The committee may use institutional or outside consultants, if needed. Plans to include committee members or consultants from outside institutions may be described, but such individuals should not be named. The committee is a formal part of the structure of the Program. It should meet regularly and keep written minutes, which will be reviewed as part of competing and noncompeting applications.

Evaluation Plan

The application must describe an evaluation plan to review and determine the quality and effectiveness of the career development program.  The evaluation plan is should include plans to obtain feedback from current and former scholars to help identify weaknesses in the program and to provide suggestions for program improvements, as well as plans for assessing scholars’ career development and progression, including publications, and subsequent positions. 

The plan should evaluate the K12 program’s curriculum, program staff, recruitment goals and practices (including recruitment of women and individuals from diverse backgrounds).

Evaluation results should be included in future renewal applications and as part of the Final Progress Report.

PI Credential (e.g., Agency Login)

The NIH requires the Principal Investigator to fill in his/her Commons User ID in the “PROFILE – Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS 398 Research Training Program Plan Component Sections

Page limitations of the Research Career Development Program Plan (uploaded using the PHS398 Research Training Program Plan) component must be followed as outlined in the SF424 (R&R) Application Guide, Section 8, Supplemental Instructions for the Institutional NRSA Application.

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, with the following requirements for K12 applications.  These instructions have been adapted to accommodate the PHS 398 and this K12 program.  Applicants should refer regularly to sections of this announcement that delineate Other Submission Requirements and Review and Selection Process.   

·         Introduction to Application (Item 1): (for Resubmission or Revision only): same as instructed in 8.7.

·         Background (Item 2): Provide the rationale for the proposed program, relevant background history, and the need for the career development program proposed. Summarize the research career development activities of the major participating unit(s) and department(s) represented in the proposed program. Include the names and roles of participating faculty members planned to contribute to the program.

Program Plan (Item 3):   

Include the following sections:

The career development program plan should clearly show how the purpose and objectives meet the intent of NICHD to support the development of independent pediatrician-scientists.  It is expected that the didactic and research experiences provided by the K12 program will facilitate the ability of the participants to acquire the necessary knowledge and research skills in scientific areas relevant to their career goals. The application should contain a description of how the career development plan will be tailored to the needs and levels of research experience of the prospective candidates. This individualized design may require career development programs that range from two to five years, depending upon the Scholar.

Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as:  individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research.  Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.  The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:  

A.    Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/nsf07308/content.cfm?pub_id=3633&id=3 ).  In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B.    Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C.    Individuals from disadvantaged backgrounds who are defined as:

1.     Individuals who come from a family with an annual income below established low-income thresholds.  These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs.  The Secretary periodically publishes these income levels at HHS - Poverty Guidelines, Research, and Measurement. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans:  Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2.     Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. 

Recruitment and retention plans related to a disadvantaged background (C1 and C2) are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.  Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background.  Such decisions will be made on a case-by-case basis, based on appropriate documentation.

Competing continuation and non-competing applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:

For those Scholars who were enrolled in the career development program, the report should include information about the duration of research career development and whether those Scholars finished their training in good standing.

This Program Announcement requires all applicants to submit a recruitment and retention plan to enhance diversity (see SF424, Section 8.7. Research Training Program Plan Components, Item 4, Recruitment and Retention to Enhance Diversity).  Additional information on the required Recruitment and Retention Plan to Enhance Diversity is available at Frequently Asked Questions Recruitment and Retention Plan to Enhance Diversity (Diversity FAQs).

SF424 R&R Cover Component

Project/Performance Site Locations Component

Indicate where the career development program described in the Research and Career Development Plans will be conducted. Include collaborating sites, if appropriate.

If multiple sites are involved in the institutional career development program, the applicant institution must be one of these sites for the program.  A justification must be included for sites other than the applicant institution in the program narrative.   

Research and Related (R&R) Other Project Information Component

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.

Data Sharing Plan: Not Applicable.

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.

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/.

The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award.  Evaluation of annual non-competing progress reports will include assessment of the dissemination practice by the grantee.  The adequacy of the resources sharing plan and will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting.”

Senior/Key Person Profile(s) Component

The Principal Investigator: The PI must be registered in the eRA Commons and be assigned the PI role within the Commons. Follow the instructions in Part I.2 which provides information regarding required registration in the eRA Commons.

Key Personnel must include the PD/PI as well as any other key persons, involved in developing, implementing, directing, monitoring, evaluating, who are integral to and have key roles in the proposed institutional research career development program.

See Section 4.5 of the Grants.gov Application Guide SF424 (R&R)

Complete the Profile for the PD/PI according to instructions in Section 4.5 of the Grants.gov Application Guide SF424 (R&R).

The PD/PI, applicable faculty and any other individuals whose contributions are critical to the development, management and execution of the Institutional Career Development Program Plan in a substantive, measurable way (whether or not salaries are reimbursed) should be identified as Senior/Key Persons. These would include the Principal Investigator/Program Director (PI/PD), the Training Director (TD), the mentors, and key program staff.  Do not list Advisory Committee members.  Since these efforts are not project-related research endeavors, they should not be identified in Other Support information. 

Other Personnel: See “R&R Budget Component Research & Related Budget,” Item “B” below.

Budget Component

Institutional Research Career Development Program applications will use the non-modular budget format (Research & Related Budget component) and "Just-in-Time" concepts.  See Sections II and Section IV for budgetary guidance.  Instructions for completing the R&R Budget Component are provided below. Information regarding allowable costs is provided in the specific FOA. The R&R Budget component includes three separate data entry screens (1) Sections A and B; (2) Sections C through E; and (3) Sections F through K.  Applicants must complete a separate detailed budget for each year of support requested.

R&R Budget Component Research & Related Budget: Complete for each budget period requested.

A.    Senior/Key Person: complete for all senior/key persons associated with the institutional career development program.  The Principal Investigator (PI/PD) and Training Director (TD) must be included here.

B.    Other Personnel: complete for all other personnel (including clerical and program administrative staff) associated with the institutional career development program. Include here the salary costs proposed for the planned scholars, identifying as the Project Role “Scholar”.

C.    Equipment: self-explanatory.

D.    Travel: include here any travel funds requested for senior/key persons and other personnel (i.e. those persons identified in Sections A. and B.) associated with the program.

E.    Participant/Trainee Support Costs: Do not complete this budget category (does not apply to K12 programs).

F.    Other Direct Costs: Include the funds requested for research development costs allowed for the scholars in the program, using lines 8-10 (when necessary), and itemize as appropriate and allowed for institutional career development program.

G.    Indirect Costs: Indirect costs are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment) rather than on the basis of a negotiated rate agreement.

K.    Budget Justification: provide a detailed justification for each category for which funds are requested.  For Section F, itemize each category of support costs per scholar and justify. Provide an explanation for all scholar research and development costs in the Budget Justification. 

Although many of the sections of this application are separate PDF attachments, page limitations referenced in the instructions and/or funding opportunity announcement must still be followed. Agency validations will include checks for page limits (and use of appropriate font). Some accommodation will be made for sections that, when combined, must fit within a specified limitation.

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

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.

Review Process

Applications submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines to the ICs for funding consideration.

Applications that are complete and responsive to this 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 initial merit review, all applications will:

The goals of NIH-supported research training, education, and career development programs are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate scientific areas to address the Nation’s biomedical research needs.

The NIH K12 grant mechanism is a specialized mechanism designed to foster the development of biomedical researchers through creative and innovative institutional career development programs.

Overall Impact: Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the institutional research career development  program to exert a sustained, powerful influence on the activities involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the proposed program).

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

Career Development Program Plan and Environment:

Program Director(s)/Principal Investigator(s) (PD/PIs):

Mentors:

Candidates/Scholars:

Training Record:

For renewal applications or new applications with previous CHRCDA support: 

Additional Review Criteria

As applicable for the program proposed, reviewers will consider the following additional items in the determination of scientific 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: Resubmissions are not allowed for this FOA.

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.  In addition, the committee will consider the following:

Additional Review Considerations 

As applicable for the program 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.

Diversity Recruitment and Retention Plan: Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined.  Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds. 

Training in the Responsible Conduct of Research: Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable.  Reviewers will specifically address five Instructional Components, Format, Subject Matter, Faculty Participation, Duration and Frequency, taking into account the characteristics of institutional programs, detailed in NOT-OD-10-019.  Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE.  Applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan.

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:

When relevant, reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:

Budget and Period of Support: Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed institutional career development program and the number of proposed scholars. 

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 PI will be able to access his or her Summary Statement (written critique) via the NIH 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 Notice of Award (NoA) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., “Funding Restrictions.”       

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the NICHD 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  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities

Termination of Award: When a grantee institution plans to terminate an award, program and grants management staff at the NIH funding component must be notified in writing as soon as possible. Consultation with NICHD staff is strongly encouraged when termination of the K12 program is being considered. When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the NoA must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH may terminate an award upon determination that the purpose or terms of the award are not being fulfilled.  In the event an award is terminated, NIH shall notify the grantee institution in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision period.

Change of Institution: The institutional career development program may not be transferred from one institution to another.

Change of Career Development Program: Awards are made for a specific program under the guidance and leadership of a particular PD/PI.  A change in any of these parameters requires prior approval by NICHD Staff. A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed Program. The new program will be evaluated by NICHD Staff to ensure that the Program remains within the scope of the original peer-reviewed Program. If the new program does not satisfy this requirement, the award will be terminated.

Change of PD/PI: If change of the PD/PI is necessary, support of the award is not automatic but may be continued with prior approval by NICHD Staff under the following conditions: written approval by the NIH funding component, provided that the following conditions are met.  The current PD/PI or the grantee institution must submit a written request for the change, signed by the appropriate institutional business official, to the NICHD program officer of the NIH funding component that describes the reasons for the change.  The Biographical Sketch of the proposed PD/PI including a complete listing of active research grant support, must be provided.  The information in the request must establish that the goals of the original peer-reviewed institutional career development program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the program.  This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review. 

Other Income: Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient.  Such fees must be assigned to the grantee institution for disposition by any of the following methods:

Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted.  The awarding component will give consideration to approval for the use of released funds only under unusual circumstances.  Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component.

Special Leave: Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed three months.  For longer periods, prior written approval of the NIH awarding institute or center is required.  Details on the process for submission of prior approval requests can be found in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600130). A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made.  Support from the K12 award will continue during such leave.

Leave without award support may not exceed 12 months.  Such leave requires the prior written approval of the NIH component institute and will be granted only in unusual situations. Support from other sources is permissible during the period of leave without award support.  Such leave does not reduce the total number of months of program support for which an individual is eligible.

Under pressing personal circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75%.  Such requests will be considered on a case-by-case basis during the award period.  In no case will it be permissible to work at less than 50% effort.  The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care.  Permission to reduce the level of effort will not be approved to accommodate job opportunities, clinical practice, or clinical training.  In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee.  In addition, the awardee must submit assurance of his/her intention to return to at least 75% as soon as possible.  During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

3. Reporting

Complete applications with detailed budgets and progress reports are required annually. K12 awards are NOT subject to the streamlined non-competing application process (SNAP). 

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

The Progress Report should provide information on the development and implementation of the proposed career development program (including training and education in the responsible conduct of research), any modifications to the career development program as originally proposed, details about the applicant pool and the participating scholars including their career level(s), gender, and racial/ethnic backgrounds (if applicable), updates on the evaluation of the program, and a list of any publications and/or other materials arising from the program.

This report should provide information about changes in the Program, a summary of any ongoing evaluation results, a summary report from the Program Advisory Committee (including information about newly selected candidates, if applicable), and a description of the research and career progress of each candidate. An overview of each scholar's research accomplishments and goals for the coming year should be clearly stated. These Annual Progress Reports will be closely monitored by NICHD staff to ensure that the grant is achieving the goals of the CHRCDA program and to confirm that the institution is continuing to meet its goal of recruiting promising investigators, and facilitating their career development.

The following information should be provided.

1.     Complete the Face Page A as instructed in the Form PHS 2590.

2.     Budget pages:

a.     Administration Budget to include all program related costs other than Scholar support. All other administrative budgetary information (e.g., supplies, travel, research support) for each selected candidate should also be provided.

b.    Scholars' Budget to include the categorical budget if Scholar is appointed and project is defined. The budget page should provide the salary and fringe benefits for each Scholar, as well as the research and development component costs.

c.     Composite Summary Budget containing the Administrative and Scholars' budgets.

3.     Include completed updated other support information for the Program Director  and PI

4.     Add biographical sketches, other support and other pertinent information for any new Key Personnel added since the last application. This includes new mentors, new Advisory Committee members, and newly selected Scholar candidates.

5.     Recruitment: What outreach was performed? Provide number of candidates applying, interviewed, and accepted.

6.     A summary of Advisory Committee roles and activities for the past year: Include the Advisory Committee minutes and if a program evaluation was performed, provide a summary.

7.     A description of course work, seminars, and other activities associated with the program.

8.     Individual Progress Report for each current Scholar: A brief summary for each appointed Scholar that describes the current research and specific plans for the upcoming year. Include information about the Scholar’s efforts to obtain independent support.

9.     Training in responsible conduct of research: All Scholars must participate in this activity during their period of K12 support.

10.  List the following:  Other Grant Support in which the Scholar is the PI (include grants applied for and awarded), presentations, awards or other recognition.

3.A. Additional Reporting Requirements

Financial Status Report (FSR): An annual FSR is required and must be submitted within 90 days of the end of each budget period.  Continuation support will not be provided until the required form is submitted and accepted.

Evaluation: In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program.  Accordingly, award recipients are hereby notified that they may be contacted after completion of this award for periodic updates on various aspects of program development, implementation, and other information helpful in evaluating the impact of this program.

Publication and Sharing of Research Results: Investigators are encouraged to submit reports of their findings for publication to the journals of their choice.  For each publication that results from this award, NIH support should be acknowledged by a footnote in language similar to the following: “This project was supported by NIH grant number ________.  Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.”

Failure by the grantee institution to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.  Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm.

Final Reports: A final Progress Report and Financial Status Report are required when an award is terminated.  Evaluation results should be included as part of the Final Progress Report.

Scholar Selection Requirements: The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar selected or returning to the K12 program.  This form must be submitted to the awarding IC at or before the start of each scholar’s appointment or re-appointment.   When applicable, a notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271).  Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm

If registered in the NIH eRA Commons, grantees may submit the PHS 2271 data electronically using the xTrain system.  More information on xTrain is available at https://commons.era.nih.gov/commons/.

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:

Karen Winer M.D
Endocrinology, Nutrition, Growth Branch
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B11, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 for courier/non-USPS service
Telephone: (301) 435-6877
Fax: (301) 480-9791
Email: winerk@mail.nih.gov

2. Peer Review Contacts:

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 courier/non-USPS service
Telephone: (301) 496-1485
FAX: (301) 402-4104

3. Financial or Grants Management Contacts:

Rehana A. Chowdhury
Grants Management Specialist
The National Institute of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Blvd - Room 8A01
Bethesda, MD  20892-7510
Rockville, MD 20852 for courier/non-USPS service
Phone: 301-435-7007
Fax: 301-451-5510
Email: rchowdhu@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 (45 CFR 46) 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 institutional review board (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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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 SF424 (R&R) application; 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, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). 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 (HHS) 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 HHS 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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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 Part 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 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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NIH Funding Opportunities and Notices


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