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
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov)

Title:  NICHD Career Transition Award (K22)
 
Announcement Type
This is a reissue of PAR-98-025, which was previously released February 2, 1998

Looking Ahead:  As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov.  For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide for Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) are required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.

Program Announcement (PA) Number: PAR-06-078

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: November 21, 2005 
Letters of Intent Receipt Date(s): January 3, 2006, September 1, 2006, September 1, 2007, September 1, 2008
Application Submission Dates: February 1, 2006; October 1, 2006; October 1, 2007; October 1, 2008
Peer Review Date(s): June/July 2006; February/March 2007; February/March 2008; February/March 2009
Council Review Date(s): September 2006; June 2007; June 2008; June 2009
Earliest Anticipated Start Date: September 2006
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: October 2, 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 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 and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

An important element of the National Institute of Child Health and Human Development (NICHD) mission is to develop the next generation of exceptionally talented new scientists who are committed to biomedical and behavioral research projects relevant to the NICHD research program.  The overall goals of this career development program are to enable outstanding individuals to obtain research training in the NICHD Division of Intramural Research (DIR) and to facilitate their successful transition to an extramural environment as independent researchers.  The Career Transition Award (CTA) will provide Fellows with at least two years of support for research training in an NICHD intramural laboratory and two years of support for an independent research project at an extramural institution.  It is anticipated that awardees will subsequently obtain a research project grant (R01) to support the continuation of this work.

Background

The Congress of the United States enacted the National Research Service Act Program in 1974 to help ensure that highly trained scientists would be available in adequate numbers and in appropriate research areas to carry out the Nation's biomedical and behavioral research agenda. Under this Congressional authority, the NICHD awards the Intramural Research Training Award (IRTA) to the most promising applicants to support full-time research training related to the mission of the NICHD.  The goal of this and other postdoctoral training programs is to develop the next generation of exceptionally talented new scientists who are committed to research related to the mission of the NICHD.  The NICHD has determined that there is a need for a mechanism to assist exceptionally talented intramural investigators in making the career transition from postdoctoral training to independent academic research positions.  To meet this need, the NICHD is reissuing the Program Announcement for the Career Transition Award Program to facilitate the transition of the most talented postdoctoral investigators into career positions relevant to the research priorities of the NICHD.

Program

The NICHD intramural research environment has provided a unique opportunity for the training of new scientists who have subsequently entered the extramural biomedical research community and have become leaders in their fields of investigation.  The goal of the NICHD K22 program is to provide highly qualified new investigators with an opportunity to receive a research and research training experience in the NICHD DIR and provide them with competitive support to facilitate the transition of their research programs to extramural institutions.

The NICHD CTA consists of an intramural phase and an extramural phase.  The total period of combined support at NICHD and at the extramural institution is up to four years.  The initial phase (up to two years) of the research training program will be an Intramural Support Phase in which the salary will be commensurate with his/her level of experience. The final two years of the program, the Extramural Support Phase, will provide salary and funds for supplies, equipment and technical support through the NIH Career Transition Award (K22) at an extramural institution/organization at which the individual has been recruited into a tenure-track or equivalent position.

Scope

The NICHD CTA Program is designed for exceptionally talented new investigators who are engaged in basic or clinical biomedical or behavioral research that is relevant to the NICHD mission and who have demonstrated outstanding scientific abilities during their training.  CTA Scholars are expected to design and pursue their research projects independently in their areas of interest.  It is anticipated that the successful applicant will use the award to establish an independent research program at an extramural institution and obtain preliminary data that will be the basis for a future research project grant application.

Interdisciplinary research is a particular emphasis of the NIH and NICHD mission for 2006 and the foreseeable future. This is understood to mean that two or more disciplines will integrate and, from that convergence, a new discipline may emerge.  This is distinct from a multidisciplinary approach that brings together experts from diverse disciplines to address a complex problem from each unique perspective.  A postdoctoral fellow engaged in interdisciplinary research will typically work as a team member with multiple investigators and will be able to demonstrate both theoretical and experimental-analytical approaches to research questions designed to solve a biomedical and/or behavioral research problem in a novel way. 

The NICHD DIR, located on the NIH Bethesda campus, is broadly concerned with the biological and neurobiological, medical and behavioral aspects of normal and abnormal human development.  In addition to five major clinical research and training programs in the areas of genetics, endocrinology and maternal-fetal medicine, a diversity of developmental models are under study in eighteen fundamental research Laboratories and Branches, drawing upon observations in bacteria, Drosophila, plants (Arabidopsis), yeast, viruses, mollusks, zebrafish, frogs, rodents (including transgenic and gene knock-out mice), and subhuman primates.  Disciplines employed in these studies include molecular biology, biochemistry, virology, immunology, pharmacology, genetics, cell and neuronal biology, biophysics, mathematical and theoretical biology, electrophysiology, reproductive physiology, structural biology, and developmental psychology.  The Intramural Research Program is carried out mainly in five laboratory-building complexes on the Bethesda campus as well as the Poolesville (Maryland) Primatology Center and several other local research sites.  The Division comprises about 100 independent research groups with a total staff of about 1,000.

A description of the NICHD Intramural Research Program and the Division’s Annual Report are available at:  http://dir2.nichd.nih.gov/.

It is anticipated that the NICHD DIR may utilize the CTA as a mechanism to recruit highly qualified new investigators to Intramural laboratories.  These talented investigators would receive research and research training experience in an NICHD fellowship program (i.e., IRTA program, Title 42 clinical fellowship) and would be eligible to compete for the NICHD K22 award.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH Career Transition Award (K22) mechanism.  As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.  The total period of support for the extramural award is two years.  Only one revision of a previously reviewed NICHD CTA  grant application may be submitted.  The K22 award is not renewable or transferable to another Principal Investigator.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

Transition from the intramural phase of support to the extramural phase is not automatic.  Approval of the transition will be based on the success of the Scholar's research program as determined by a formal NICHD scientific progress review, which will take place no later than two months before the end of the second year of the Intramural Support Phase, and the evaluation of a research plan to be carried out at the extramural institution.  Scholars approved to proceed with the second phase of support will receive notification of approval in writing from the NICHD.  The extramural institution must demonstrate a commitment to the Candidate by providing protected research time and space needed to perform the proposed research.  Support from the institution for equipment and supplies (and, if necessary, salary) is encouraged.  Once an acceptable application has been submitted by the extramural institution on behalf of the Candidate, the NICHD will begin the steps to issue a grant award.

Acceptance into the NICHD CTA Program does not guarantee the transition to Phase II, the extramural segment.  Further, acceptance does not convey any commitment or intent of the NICHD to consider the Scholar for a tenure track position within the NICHD.  The NICHD CTA is specifically intended to help develop scientists who will pursue their careers in the extramural biomedical research community.  However, the NICHD K22 Research Scholars are not explicitly precluded from applying for available tenure track positions at the NIH.  If a Scholar obtains an NIH position, the NICHD CTA will be terminated.

2. Funds Available

For Fiscal Year 2006, the NICHD anticipates making approximately two – three awards in response to this Funding Opportunity Announcement.  The earliest anticipated start date for applicants eligible for the extramural phase is September 2006.

Intramural Support Phase:

The budget for the Intramural Support Phase includes the Candidate's salary and research expenses determined by the NICHD DIR.  There is no grant award associated with the intramural phase. Total costs for the intramural phase are based on the Candidate's experience and research expenses.  The salary will be commensurate with the level of training and experience specified by the intramural salary structure and will be negotiated with NICHD DIR prior to entering the Program.

Extramural Support Phase:

Applicants may request up to $125,000 in direct costs per year for each of two years. 

1.  Salary:  The NICHD will provide up to $75,000 in salary plus fringe benefits for the K award recipient.  The total salary requested must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned.  A minimum of 75 percent of full-time professional effort must be devoted by the Scholar specifically to the proposed research program. The institution may supplement the NIH 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.  In no case may PHS funds be used for salary supplementation.  Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the CTA.  Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. 

The CTA does not require that salary support be derived from the award; use of the entire direct costs for research-related expenses is allowed. If no salary funds are requested from the CTA, a statement should be included in the institution’s application indicating the source and amount of salary support.  If an institution commits its own funds to support the salary of a K22 recipient, NICHD will view that as further evidence of institutional commitment.

2.  Research Support:  Funds not expended for salary, up to $125,000 per year, may be used for (a) research expenses, such as supplies, equipment, and technical personnel; (b) travel to research meetings or training; and (c) statistical services, including personnel and computer time.

3.  Ancillary Personnel Support: Salary for secretarial and administrative assistance, etc. is not allowed.

4.  Facilities and Administrative (F & A) costs:  All F & A costs will be reimbursed at eight percent of modified total direct costs, or at the actual F & A cost rate, whichever is less.

Effective for all new competing research project grant applications, mentored career award recipients in the last two years of career award support may be eligible to reduce effort on the career award to a minimum of 50 percent 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 of the research grant.  This policy is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

Intramural Support Phase:

Applications for the initial Intramural Support Phase may be submitted by the NICHD DIR on behalf of the Candidate.

Extramural Support Phase:

Applications for transition to the extramural phase may be submitted by an extramural institution with any of the following characteristics:

Foreign institutions are not eligible to apply.

1.B. Eligible Individuals

Intramural Support Phase:

Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with the NICHD DIR to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

At time of submission, applicants must:

At the time of award, Candidates must:

Individuals are NOT eligible if they:

Applicants are strongly encouraged to consult with the Intramural scientific/research contact person listed in Section VII of this announcement prior to the submission of an application to discuss eligibility and program requirements.

Extramural Support Phase:

To become eligible for the Extramural Support Phase, the CTA Scholar must have received notification of eligibility from the NICHD Office of the Director and have obtained a tenure track or equivalent position from an eligible extramural institution.  See Transition to Extramural Support Phase, Section V.2.E, below, for additional information.

2. Cost Sharing or Matching

 Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

Applicants may submit only one application in response to this announcement.

A Candidate for the K22 award may not simultaneously submit or have an application pending for any other NIH career award (e.g., K01, K07, K08, K22, K23, K25), a research project grant (R01), or any PHS award that duplicates any of the provisions of the K22 award. 

K22 recipients are expected to apply for independent research grant support during the Extramural Phase of the award.  Recipients of a K22 award may hold concurrent research support and, under certain circumstances (see Allowable Costs above), salary support from their career award and a competing NIH research project grant when recognized as a Principal Investigator or subproject Director of the research project grant (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html).

Each K22 career development program must be tailored to meet the individual needs of the Candidate.  The Candidate and mentor are responsible jointly for the preparation of the plan for the career development and research program.  The sponsoring institution for the Extramural Phase must demonstrate a commitment to the development of the Candidate as a productive, independent investigator.

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 on line 2 of the face page of the application form and the YES box must be checked.
 
3. Submission Dates and Times
See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates

Letter of Intent Submission Date:  January 3, 2006, September 1, 2006, September 1, 2007, September 1, 2008
Application Submission Date(s):  February 1, 2006; October 1, 2006; October 1, 2007; October 1, 2008
Peer Review Date:  June/July 2006; February/March 2007; February/March 2008; February/March 2009
Council Review Date:  September 2006; June 2007; June 2008; June 2009
Earliest Anticipated Start Date:  September 2006

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 NICHD staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Susan Taymans, Ph.D.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B01
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service; non-USPS service)
Phone:  301-496-6517
Email: taymanss@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, 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 Letters of Reference and appendix material must be sent to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD  20852 (for express/courier service; non-USPS service)

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.).

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

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

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

The following applies to the Extramural Phase of the program:

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 http://grants.nih.gov/grants/policy/policy.htm.
 
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 competing continuation award if such costs: are necessary to conduct the project, and 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 award.

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

6. Other Submission Requirements

Prospective applicants should contact the NICHD scientific/research contacts (see Section VII) to discuss eligibility and determine actions necessary to initiate the process.  The applicant must select a mentor in the NICHD DIR with whom to consult in preparing and submitting the application for the intramural postdoctoral phase of the award.  Individuals working at an NIH laboratory may work with their current mentor or with another intramural investigator, provided the research experience proposed in this application will enhance the Candidate’s scientific career.  The Candidate and the mentor must collaborate closely in preparing the application.

In addition to the application requirements described in the PHS 398 Supplementary Instructions for Research Career Awards, applicants should address the following:

Application Contents

Candidate

Career Development Plan

Research Plan

Mentor

Environment

Training in the Responsible Conduct of Research

Applications must include a description of a program to receive formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for or documentation of prior instruction in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management.  Applicants must follow the application instructions found in the PHS 398 application package and refer to the NIH Website (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

Document prior instruction in or propose plans for instruction in the responsible conduct of research in terms of subject matter and duration of instruction.  An award cannot be made if an application lacks this component.

Letters of Reference

Include with the application three sealed letters of reference from well-established scientists addressing the above areas and any other evidence that the Candidate has a high potential for becoming a successful Candidate for this transition award program.  The mentor(s) may also submit letters of reference, but these letters will be considered independently of the three required reference letters.  Letters of reference should be sent directly to the NICHD Division of Scientific Review (see Section IV.3.B).

Plan for Sharing Research Data
A plan for sharing research data is not required.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131. Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan 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.

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 submitted in response to this funding opportunity will be assigned to NICHD.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by the NICHD in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The following will be considered in making funding decisions:

The goal of this initiative is to facilitate a new investigator’s ability to transition from a postdoctoral trainee to an independent scientist capable of applying for and receiving his/her first R01 award and securing a stable research position.  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 and career development plans will have a substantial impact on the pursuit of these goals.

Candidate

Candidate

Career Development Plan

Research Plan

Reviewers recognize that an individual with limited research experience is less likely to be able to prepare a research plan with the depth and breadth of one submitted by a more experienced investigator. Nevertheless, a fundamentally sound research plan must be provided.

Mentor

Environment

Training in the Responsible Conduct of Research

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 priority score:

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 E on Human Subjects in the PHS Form 398).

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 E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research:  If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions 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 research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data
A data sharing plan is not required.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps and http://www.ott.nih.gov/policy/rt_guide_final.html. Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by NICHD Program staff when making recommendations about funding applications. Program staff may negotiate modifications of the resource sharing plans with the Principal Investigator before recommending funding of an application. The final version of the resources sharing plans negotiated by both will become a condition of the award of the grant. 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.  

2.E.  Selection Procedures

Intramural Support Phase:

Following peer review, all scored K22 applications will be considered by a committee of senior NICHD Intramural and Extramural staff.  Highly meritorious Candidates will be selected for the Intramural Phase on the basis of scientific and technical merit, as determined by peer review, and programmatic needs.  Candidates will be notified in writing of the outcome of this selection process.

Transition to Extramural Support Phase

(1)  The NICHD will conduct a formal scientific progress review no later than two months before the end of the second year of the Intramural Support Phase.  Candidates must provide a progress report using form PHS 2590, available at http://grants.nih.gov/grants/forms.htm.  The form is due at least two months prior to the end of the budget period.  The report should detail progress achieved on the specific aims of the research plan and on the pursuit of identified career and career development goals.  Future goals for the research project and for further career development should also be indicated.  The mentor must provide a separate narrative of the research and career development of the Candidate.

(2) Determination of eligibility for the Extramural Phase will be based upon the cumulative research progress and evidence of increasing scientific independence, as documented by both the Candidate and the mentor.  The results of the review will be communicated to the Candidate, mentor, and NICHD Scientific Director.  The successful Candidate will be provided with a letter of eligibility with which he/she may pursue a tenure track appointment. 

(3)  To activate the Extramural Phase of the grant, individuals must have been offered and accepted a tenure-track, full-time assistant professor position (or equivalent) at an institution with a history of rigorous research programs and extensive outside research funding.

(4)  After the Candidate receives approval in writing for the transition to extramural support, the extramural institution offering the Candidate a tenure-track (or equivalent) position will submit a form PHS 2590 noncompeting application.  The application should include the following:

(5)  The application submitted by the Candidate and the extramural institution for activation of the Extramural Phase will be evaluated by NICHD Extramural Staff.   If extramural funding is approved, the applicant institution will receive an award notice as described in Section VI.1.

Approval of the transition to the Extramural Support Phase could be made at any time prior to the end of the second year of the Intramural Support Phase.  Whenever review and approval occur, the Candidate remains eligible for up to one additional year of intramural support.  However, any remaining unused portion of the Intramural Support Phase will not be carried over into the two-year Extramural Support Phase.

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

For the Extramural Phase: 

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA 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 Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Periodic updates on various aspects of 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 may be solicited from awardees.

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:

Extramural Scientific/Research Contact:

Susan Taymans, Ph.D.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B01
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service; non-USPS service)
Phone:  301-496-6517
Email: taymanss@mail.nih.gov

Intramural Scientific/Research Contact:

Brenda R. Hanning
Director, Office of Education
Division of Intramural Research
National Institute of Child Health and Human Development
31 Center Drive, Room 2A31, MSC 2425
Bethesda, MD 20892-2425
Telephone:  (301) 451-7753
FAX:  (301) 480-3869
Email:  hanningb@mail.nih.gov  

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

Robin Kurtz
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A07E, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 435-6978
FAX: (301) 451-5510
Email:  rkurtz@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).

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/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:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).

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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 PA 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/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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