PAR-08-047: NCI Transition Career Development Award to Promote Diversity (K22)

Department of Health
and Human Services (HHS)

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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 Cancer Institute (NCI) (http://www.cancer.gov)

Title: NCI Transition Career Development Award to Promote Diversity (K22)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of PAR-05-011, which was released on November 2, 2004.

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

December 31, 2008 - This PA has been reissued as PAR-09-069.

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2007 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications using those mechanisms 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 to 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) is 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-08-047

Catalog of Federal Domestic Assistance Number(s)
93.398

Key Dates
Release Date: December 17, 2007
Letters of Intent Receipt Dates: Not applicable.
Application Submission Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm.
Peer Review Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm.
Council Review Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm.
Earliest Anticipated Start Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm.
Additional Information To Be Available Date (URL Activation Date): Not applicable.
Expiration Date: January 8, 2009 (per PAR-09-069) - Originally: January 8, 2011

Due Dates for E.O. 12372

Not Applicable.

Additional Overview Content

Executive Summary

Purpose. This Funding Opportunity Announcement (FOA) represents the continuation of an NCI program to make possible the diversification of the cancer research workforce via facilitation of the transition of investigators from minority groups underrepresented in biomedical research, primarily those with clinical doctoral degrees as well as those with doctoral degrees working in the areas of cancer prevention, control, behavioral, or population science research, from the mentored stage of career development in academic cancer research to the independent stage. This goal is achieved by providing protected time through salary and research support for 3 years to: postdoctoral individuals or junior faculty in mentored positions transitioning into their first independent position; and investigators within the first 2 years of their first independent cancer research position, to initiate and develop their independently-supported cancer research programs.

Mechanism of Support. This FOA will use the NIH K22 Career Development Award mechanism.
Budget and Project Period. The award will provide 3 years of salary (up to $75,000 per annum plus fringe benefits) and research support up to $50,000 per annum.
Eligible Project Directors/Principal Investigators (PDs/PIs). Eligible candidates for an award must be: individuals with a clinical doctoral degree (e.g., M.D., D.V.M., D.O.), oncology nurses with a doctoral degree or clinical psychologists with a doctoral degree, who are pursuing basic science cancer research careers or careers in patient-oriented cancer research; or 2) individuals with a doctoral degree (e.g., Ph.D., M.D., Dr.P.H.) in the areas of cancer prevention, control, behavioral or population science. Federally employed basic scientists holding a doctoral degree (e.g., Ph.D., M.D.) are eligible candidates if they are working in human cancer research. Individuals who meet these requirements must also qualify as an individual representative of minority groups underrepresented in biomedical research and must have completed a minimum of 2 YEARS of postdoctoral CANCER research training and be ready to pursue an independent career at the time of application OR be in an independent faculty position for LESS THAN 2 YEARS with continuous previous postdoctoral CANCER research training at the time of the application. Eligible candidates for an award must be citizens or non-citizen nationals of the United States (U.S.), or must have been lawfully admitted to the U.S. for permanent residence at the time an offer of an award is made. Individuals on temporary visas are not eligible.
First independent position is defined as the Assistant Professor level or an equivalent permanent faculty position (e.g., Assistant Member, Laboratory Head, Principal Investigator, etc.), at which the candidate is expected to establish his/her own independent research program, prepare applications for regular (non-career development) research funding, and act as a Principal Investigator (PI) on such independent research projects.
Eligible Institutions/Organizations. Applicants may apply for this award WITHOUT an institutional affiliation. These individuals will have up to 12 months to identify and accept an appropriate independent non-Federal research position and activate the K22 award. The K22 application may be submitted on behalf of the candidate (i.e., the PI) by any domestic for-profit or non-profit institution/organization, or by public or private institutions, such as universities, colleges, hospitals, and laboratories. Foreign institutions and organizations are not eligible to apply.
Eligible candidates must be able to devote a minimum of 75 percent of full-time professional effort to the objectives of the K22 award, i.e., development into an independent investigator.
Planning, direction, and execution of the proposed K22 award are the responsibility of the applicant (i.e., the PI).
A candidate for the K22 award may not apply concurrently for or have an award pending for another U.S. Public Health Service (PHS) or non-PHS award that duplicates the provisions of the K22 award. However, a candidate may have been or currently be the PI of an NIH K08 or K23 Career Development Award; NCI K07 Cancer Prevention, Control, Behavioral and Population Sciences Career Development Award or K25 NCI Career Development Award for Quantitative Scientists (RFA-CA-04-016) ; NIH R03 or R21 grant; or non-PHS equivalent grant at the time of application. A current appointee to an NCI K12 grant is also eligible to apply. However, a successful candidate must terminate any other active mentored K award upon acceptance of the K22 award.
Renewals and Resubmissions. Awards are neither renewable nor transferable from one PI to another. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed K22 grant application may be submitted.
K22 grantees are required to submit an application for an NIH independent investigator research grant or non-PHS peer-reviewed equivalent grant prior to the end of the 2nd year of support by a K22 award.
Applications must be submitted on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial 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 an application must include an introduction addressing the previous critique.
K22 grantees are required to submit an application for an NIH independent investigator research grant or non-PHS peer-reviewed equivalent grant prior to the end of the 2nd year of support by a K22 award.
Applications must be submitted on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm.
Applications must be prepared using the PHS 398 research grant application form, following the instructions for research career development award applications in Section III and the supplemental instructions contained in this FOA. See Section IV for application materials.
Telecommunications for the hearing impaired is available at: TTY 301-451-5936.
Initial merit review convened by NCI.

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. Submission, 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
1. Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Career Objectives

Purpose

This K22 mechanism is part of a continuing effort to establish a unique pathway for recruiting and retaining both advanced postdoctoral students and new investigators from groups that are underrepresented in biomedical research who can conduct independent competitive cancer programs). These biomedical research investigations are expected to address problems that are pertinent to the biology, etiology, pathogenesis, prevention, diagnosis, control, and/or treatment of human cancer.

Background

Substantial national and local efforts have been made and are continuing to be made to reduce cancer morbidity and mortality in the general population. However, despite these efforts, it is estimated that 1,444,920 men and women will be diagnosed with and 559,650 men and women will die of cancer of all sites in 2007 (ref http://www.cancer.org/downloads/STT/CAFF2007PWSecured.pdf). Past patterns of cancer incidence and mortality predict that a disproportionate share of this increase in U.S. cancer incidence and mortality will be borne by minorities. Specifically, cancer rates for stomach, liver, gall bladder, and cervix are higher in Hispanics than in non-Hispanic whites (http://www.cancer.org/downloads/STT/CAFF2006HispPWSecured.pdf). Both stomach and liver cancer incidence and death rates are more than twice as high in Asian American/Pacific Islanders as in Caucasians, whereas cancer mortality rates from prostate, stomach, and cervical cancers among African Americans are more than twice those in Caucasians (http://www.cancer.org/downloads/STT/CAFF2007PWSecured.pdf). A reduction in the overall cancer mortality rate in minority populations would substantially impact known cancer statistics. A major obstacle to developing a stronger national minority cancer research effort has been the lack of significant strategic training programs for minority students and scientists in cancer research. Progress in realizing a significant increase in the number of competitive minority cancer researchers had been disappointing. A greater involvement of minority candidates, who possess the appropriate cultural perspectives, is integral to a successful national minority cancer research effort involving more minority patients and populations.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity uses the NIH Career Transition (K22) funding mechanism. As an applicant, the candidate will be responsible for planning, directing, and executing the proposed research project. Applicants must request 3 years of support. Awards are not renewable. This funding opportunity uses NIH just-in-time budget concepts. It also uses the Career Development Award budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). The applicant should follow the instructions for budget information described in the PHS 398, Section III, providing only the total direct costs requested for each year and the entire proposed period of support and budget justification information.

2. Funds Available

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

Allowable Costs

Direct costs are limited to up to $75,000 per annum salary and up to $50,000 per annum for research support costs. Fringe benefits based on the sponsoring institution’s rate are provided in addition to the salary. Research support costs may include: tuition and fees related to the career development of the PI; supplies, equipment and technical personnel; travel to research meetings or training; and statistical services including personnel and computer time. The level of research support costs may be negotiated downward with the acquisition of any independent grant support from any source.

The total salary requested must be based on a full-time, 12-month staff appointment requiring candidates to devote a minimum of 75 percent of full-time professional effort to conducting health-related research with the remaining effort being devoted to activities related to the development of a successful research career. For information regarding NIH policy on determining full-time professional effort for career awards, see http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html. Candidates who have U.S. Veterans Administration (VA) appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact NCI staff (Section VII) prior to preparing an application to discuss their eligibility, qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be related appropriately to the existing salary structure. Confirmation of salary is required prior to the issuance of an award.

The sponsoring 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. In no case may additional 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 K22 award. Under expanded authorities, institutions may re-budget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary, however, may not exceed the legislatively mandated salary cap.

Ancillary personnel support: Salary for secretarial and administrative assistance, etc., is NOT allowed.

Facilities and Administrative (F&A) costs will be reimbursed at 8 percent of modified total direct costs.

F&A costs requested by consortium participants are included in the total cost limitation; see NOT-OD-05-004. Such costs, however, are limited to 8 percent of modified direct costs.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your institution has any of the following characteristics:

For-profit organizations;
Non-profit organizations;
Public or private institutions, such as universities, colleges, hospitals, and laboratories;
Units of State government;
Units of local government;
Eligible agencies of Federal government; and
Domestic institutions only.

The institution must be able to demonstrate a commitment to the development of the research careers of junior underrepresented minority research scientists in biomedical cancer research.

1.B. Eligible Individuals

Applicants are encouraged to contact the NCI program staff listed under Section VII. Agency Contacts, Scientific/Research Contacts regarding their eligibility for this award prior to the preparation of an application. Recipients of the NCI Mentored Career Development Award to Promote Diversity and/or candidates who meet the following requirements are eligible to apply:

Qualify as an underrepresented minority individual defined as individuals belonging to particular ethnic, racial, and other groups determined by the grantee institution to be underrepresented in biomedical, behavioral, clinical, or social sciences, e.g., first generation college students/graduates, socio-economically disadvantaged persons, or persons with disabilities. Individuals with disabilities are defined as those with a physical or mental impairment which substantially limits one or more major life activities.
Possess a research or health professional doctoral degree (or its equivalent) that is suitable preparation for a productive research career, e.g., Ph.D., M.D., Dr.P.H., in the areas of biomedical, behavioral, basic, clinical, or social science cancer research.

Individuals who meet the requirements stated above must have been in or currently be in a "mentored" research postdoctoral position and have completed a minimum of 2 years or more of research training in this capacity at the time of the application, or be in a suitable independent position for less than 2 years with continuous previous postdoctoral research training at the time of the application (exceptions to this condition will require explicit written permission from the NCI); and

Intend to conduct a research project highly relevant to cancer biology, etiology, pathogenesis, prevention, diagnosis, and/or treatment that has the potential for establishing an independent research program.

Eligible candidates must also be able to devote a minimum of 75 percent (9 calendar months) of full-time professional effort to the Award. The remaining 25 percent can be divided among other research, clinical, and teaching activities only if these activities are consistent with the goals of the K22 Award, i.e., the candidate's development into an independent investigator.

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

Applicants may apply for this award WITHOUT an institutional affiliation.

An individual is NOT eligible to apply if he/she:

has simultaneously submitted any other PHS or non-PHS or non-Federal award that duplicates the provisions of the K22 award (however, an individual may concurrently submit an application for an NIH R03 or R21 grant or any PHS or non-Federal award that duplicates the provisions of an R03 or R21 grant and remain eligible for an NCI K22 award);
has been or is currently PI on an NIH Pathway to Independence (PI) Award (K99/R00);
has been or is currently PI on an NIH research grant (e.g., R01, R29, P01) or Project Leader on Program Project (P01) and/or Center Grant (P50), or non-NIH-equivalent to these grants/awards; and/or
has been or is currently PI on a peer-reviewed non-NIH research grant over $100,000 in direct costs per year intended for independent investigators.

Applicants are strongly encouraged to consult with the NCI scientific/research contact person listed in Section VII of this announcement prior to submitting an application to discuss issues of eligibility and review the specific provisions/requirements of this program.

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

Special Requirements

The NCI Transition Career Development Award (K22) to Promote Diversity can be used by more advanced postdoctoral and newly independent minority candidates who need protected time to establish their initial cancer research program.

Candidates must devote at least 75 percent (i.e., 9 calendar months) of their full-time professional effort to cancer-related research. The candidate must develop advanced knowledge in the basic, clinical, prevention, or population-based sciences and the advanced research skills relevant to her/his cancer research field(s). The remaining 25 percent can be divided among other activities only if they are consistent with the program goals, i.e., the candidate's development into an independent investigator.

Recipients of an NCI Transition Career Development Award to Promote Diversity (K22) must submit a competitive research grant application to the NIH/NCI, or an R01 equivalent research grant application to an equivalent funding organization (for example, an American Cancer Society Research Project Grant) for peer review and funding consideration prior to the end of the second year of support.

The sponsoring institution, once identified, must have well-established basic, clinical, and/or prevention and population-based cancer research programs. The candidate's proposed cancer research program should benefit from the relevant cancer research and educational resources that are available. The sponsoring institution must also demonstrate a commitment to the development of junior faculty as productive, independent investigators.

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 Grants Info -- Telephone: (301) 710-0267; 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 Dun & Bradstreet (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 the face page of the PHS 398 form. Candidates applying without an institutional affiliation will not need to provide this information until the award is ready to be activated.

The title and number of this funding opportunity must be typed on the face page of the application form and the YES box must be checked.

Applicants should follow the instructions in the PHS 398 application for Individual Research Career Development Awards (See: http://grants.nih.gov/grants/funding/phs398/phs398.pdf) and complete ALL the required sections with the following modifications.

Note that new and revised applications responding to this announcement must include at least three sealed letters of reference attached to the face page of the original application. Applications submitted without the required number of reference letters will be considered incomplete and will be returned without review.

The application must address the following issues:

Candidate

Applicants already in an independent position should describe:

the current position in terms of its ability to enable the candidate to pursue an independent career in cancer research.

All Applicants

All applicants should describe:

their immediate and long-term career goals, explaining how the award will contribute to their attainment;
all of their activities during the "mentored" period (postdoctoral, previous K-award, etc.) of cancer research training (applicants should include all research experiences and mentors, any pertinent didactic experiences and any other experiences designed to acquire critical skills, techniques, and scientific perspectives for pursuing an independent career in the chosen area of cancer research [e.g., basic research, clinical, or patient-oriented research, and prevention, control, and population research]);
their scientific productivity during the mentored period of career development;
their potential to manage an independent research program;
how this award will lead to submission of a competitive research grant to the NIH/NCI or R01 equivalent research grant application to an equivalent funding organization for peer review and funding consideration prior to the end of the second year of support and their ability to become an independent investigator during the 3-year term of the award;
their ability to interact and collaborate with other scientists; and
their ability to make a commitment of at least 75 percent effort (9 calendar months) to the objectives of this award.

All applicants must:

Submit three letters of recommendation from established scientists familiar with the candidate's potential and capability to become a successful independent investigator; each letter should address the following issues;

the adequacy of the candidate's scientific background for the proposed research and career goals;
the quality of the candidate's scientific productivity and achievements (e.g., publications, intellectual contributions to the research environment);
the candidate's ability to work with other scientists in various interactive situations (e.g., seminars, journal clubs), on collaborative research projects, and with support staff (e.g., technicians, nurses, secretaries etc.);
evidence of the candidate's originality and innovativeness in pursuing a research problem; and
the candidate's special potential to develop, establish, and manage an independent research program.

In the Research Plan, applicants should:

Describe the research plan using Form PHS 398 (http://grants.nih.gov/grants/funding/phs398/phs398.pdf) following instructions for the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods -- the research plan must be clearly relevant to cancer biology, etiology, pathogenesis, prevention, diagnosis, and/or treatment;
Describe how the proposed research extends the mentored research training that has been completed into new concepts and ideas;
Describe the equipment, specialized facilities, and personnel resources that will be needed to conduct the proposed research;
Describe the plans for inclusion of women, minorities, and children in any clinical or population research activities; and
Describe the plans for protection of humans, animals, or the environment to the extent they may be adversely affected by activities proposed in the application.

Previous Mentor's Statement should include:

a signed statement from the previous mentor(s) with information on potential and capability of the candidate to become a successful independent investigator in which the following issues are addressed;
an assessment of the adequacy of the candidate's scientific background for the proposed research and career goals;
an assessment of the quality of the candidate's scientific productivity, and achievements (e.g., publications, intellectual contributions to the research environment);
assessments of the candidate's ability to work with other scientists in various interactive situations (e.g., seminars, journal clubs), on collaborative research projects, and with support staff (e.g., technicians, nurses, secretaries, etc.,) as well as of their research qualifications and previous experience(s) as a postdoctoral researcher; and
information to describe the previous mentor's research support as related to the candidate's research plan.

Environment and Institutional Commitment should be documented by descriptions of:

the resources and facilities available to the candidate; and
how the research environment of the institution is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.

In a clear statement, the appropriate representative of the applicant institution should also provide assurances that the candidate will be able to spend a minimum of 75 percent effort (9 calendar months) in the conduct of his/her research activities, with the remaining percent effort devoted to activities related to the development of a research career.

Biographical Sketch

A biographical sketch is required for the candidate, including information on research projects completed and/or research grants participated in during the postdoctoral or mentored phase that are relevant to the proposed project.

Training in the Responsible Conduct of Research

Applicants must either: document receiving prior instruction covering the responsible conduct of research; or outline plans how and when they expect to receive such instruction. The plans should include a description of a formal program or informal training (in terms of subject matter and duration of instruction) on scientific integrity and the responsible conduct of research.

Applications without either documented prior training or plans for instructions in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. An award cannot be made if an application lacks this component.

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 on page 49 of the PHS 398 application package and refer to the NIH Web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

Budget

The total direct costs requested must be consistent with this K22 program announcement and the award limits of the NCI. The award will provide 3 years of salary (up to $75,000 per annum) plus fringe benefits, and up to $50,000 annually for research and development expenses. Provide a detailed description, with justification, for all equipment, supplies, and personnel that are required to achieve the research objectives of this award.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Letter of Intent Receipt Date: Not applicable
Application Submission Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Peer Review Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Council Review Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Earliest Anticipated Start Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.

3.A.1. Letter of Intent

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

3.B. Sending an Application to the NIH

Applications must be prepared using the career development award (CDA) application forms found in the PHS 398 instructions for preparing a research career award application. Submit a signed, typewritten original of the application, including the checklist, three original sealed letters of reference, 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 (for U.S. Postal Service express or regular mail)
Bethesda, MD 20817 (for non-USPS delivery)
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, including copies of all appendix materials, must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)

Appendices should be comprised of single-sided, unbound materials, with separators between documents.

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. Upon receipt, applications will be evaluated for completeness by NCI staff.

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. 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.

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement which 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 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 the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Letters of Reference

Note that new and resubmission applications responding to this announcement must include at least three sealed letters of reference attached to the face page of the original application. Applications submitted without the required number of reference letters will be considered incomplete and will be returned without review.

Plan for Sharing Research Data

A plan for sharing research data is not required.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. See the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131. Applicants must acknowledge in the application that unique research resources generated with the NIH support will be subject to sharing in accordance with the NIH policies or explain why sharing of certain resources might not be possible.

The adequacy of the resources sharing statement 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, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

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

Applications that are complete and responsive will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI in accordance with the review criteria stated below. Incomplete and/or non-responsive applications will not be reviewed.

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

Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score;
Receive a written critique; and
Receive a second level of review by the National Cancer Advisory Board.

3. Merit Review Criteria

Applications submitted in response to a funding opportunity will compete for available funds with all other recommended applications.

The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

The following review criteria will be applied:

For candidates (i.e., Principal Investigators) already in an independent position:

Suitability of the position for the candidate to pursue an independent research career.

For all Candidates:

Quality of the mentored period of cancer research training in terms of research experience(s), didactic experiences, and other experiences (e.g., special skills, perspectives, techniques) that will enhance the candidate's ability to pursue an independent cancer research career in the chosen area of research (e.g., basic research; clinical or patient oriented research; or prevention, control, and population research);
Scientific productivity during the mentored period of cancer research training;
Commitment of the candidate to an independent cancer research career that will be focused on problems clearly relevant to cancer;
Potential ability to successfully manage an independent research project;
Ability of the candidate to interact and collaborate with other scientists; and
Recommendations of three well-established scientists attesting to the special potential of the individual to pursue an independent career in cancer research.

Research Plan:

Adequacy of the proposed research plan for developing an independent cancer research program as it relates to the basic, clinical, or patient-oriented and/or prevention control and population cancer research and commensurate with the candidate's level of research development;
The originality and quality of the research hypothesis/question, design, and methodology, judged in the context of the candidate's previous training and experience;
Adequacy of plans for the protection of human and animal subjects and the safety of the research environment and conformance with the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research and Inclusion of Children Participating in Research Involving Human Subjects. (See criteria included in the section on Federal Citations, below.)

Previous Mentor/Co-Mentor Statement:

Strength of the previous mentor's statement describing the potential and capability of the candidate to become a successful independent investigator.

Institutional Environment and Commitment:

Clear commitment of the institution to ensure that a minimum of 75 percent of the candidate's effort will be devoted directly to research, with the remaining percent effort being devoted to activities related to the successful development of a independent research career;
Adequacy of research facilities and training opportunities;
Quality and relevance of the environment for scientific and professional development of the candidate.

Training in the Responsible Conduct of Research

Document receiving prior instruction covering the responsible conduct of research; or
Outline plans how and when they expect to receive such instruction.

Budget

Justification of the requested budget in relation to career development goals and research aims and plans; and
Adequacy of the proposed budget items for the achievement of the career development and research objectives of the award.
The reasonableness of the proposed budget and the requested period of support in relation to the proposed career development award program. The priority score should not be affected by the evaluation of the budget.

3.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 Subject 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 Subject 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 (rev. 5/2001) will be assessed.

3.B. Additional Review Considerations

The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined by peer review;
Availability of funds; and
Relevance of program priorities.

Candidates who have competed successfully for funding that do not have an institution at the time funding decisions are made will be notified by the NCI with a "Letter of Intent to Commit Funds." Candidates in a postdoctoral position will then have one-year from the date of the letter to find an institution that offers a position, preferably tenure-track, suitable for enhancing a research career. Candidates who have already identified positions will not receive the "Letter of Intent to Commit," but will be asked to submit the "Statement of Environment and Institutional Commitment" and to submit the Just-In-Time documents (detailed budget for initial budget period, detailed budget for entire project period, other support and checklist). For candidates who already have a position in a sponsoring institution, negotiation with the institution will begin without delay.

Negotiations will be initiated by asking the candidate's institution to submit a "Statement of Environment and Institutional Commitment" to the NCI. This statement w ill be evaluated by NCI staff using the following criteria:

Documentation of a strong, well-established research program related to the candidate's area of interest including a high-quality research environment with staff capable of productive collaboration with the candidate;
Agreement of the institution's statement of commitment of equipment, physical and personnel resources with the peer-reviewed recommendation of needs; and
Adequacy of the arrangements with the candidate to provide a permanent preferably tenure-track position, adequate facilities for conducting a research program, and additional resources conducive to the development of a research project and establishment of a successful research career.

For postdoctoral candidates, if the NCI approves the "Statement of Environment and Institutional Commitment" offered by the institution, the institution will be asked to submit a completed PHS Form 398 application. For candidates who already have a position in a sponsoring institution, the NCI only needs to approve the Statement. After NCI approval and subject to the availability of funds, the institution will receive an award. At the time of the award to the grantee institution in support of the K22, any current award held or other support provided for the mentored training of the candidate will be terminated.

3.C. Sharing Research Data

A plan for sharing research data is not required.

3.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. See the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps and at 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 Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource 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).

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a summary statement.

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, which is found at 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.

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.

The NoA for successful candidates will be sent to the sponsoring institution's Office of Sponsored Research via e-mail or paper copy.

For candidates who have competed successfully for funding who do not have a sponsoring institution at the time funding decisions are made will be notified by NCI with a Letter of Intent to Commit Funds.

2. Administrative Requirements

All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General, at 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 at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm.

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:

The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution.
The funds may be used for health-related research purposes.
The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Office of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment.

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 NCI.

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 3 months. For longer periods, prior written approval of the NCI is required. To obtain prior approval, the award recipient must submit a letter to the NCI describing the plan, countersigned by his or her department head and the appropriate institutional official. 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 career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of NCI and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible.

In situations other than those supported in the concurrent support policy cited above, under unusual and pressing circumstances, an awardee may submit a written request to the awarding component, requesting a reduction in professional effort below 75 percent (9 calendar months). 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 a rate of less than 50 percent effort (6 calendar months). 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 other sources of funding, 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.

Furthermore, the awardee must submit assurance of his or her intention to return to full-time professional effort (at least 75 percent or 9 calendar months) as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

Change of Institution or Termination

Awardees planning a change of institution are urged to contact the NCI Program Director (name listed in Notice of Grant Award) to discuss the transfer and obtain instructions. The required paperwork must be submitted by the new institution far enough in advance of the requested effective date to permit review. The period of support requested at the new institution must be no more than the time remaining within the existing award period.

When a grantee institution plans to terminate an award, the NCI must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NCI may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NCI shall notify the grantee institution and career award recipient in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision

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.

The Progress Report (PHS form 2590) will be evaluated based upon and should include:

Demonstration of scientific progress toward the aims of the research. The candidate is responsible for a brief summary of the studies and results obtained during the prior funding period;
A list of accomplishments such as publications, inventions, or project- generated resources should be provided;
A brief explanation of plans to address the specific aims during the next year of support; and
Description of similar activities for the next year of support with a clear indication of percent effort devoted to research/research training and other activities, respectively.

In addition to the information requested in the Application for Continuation Grant form PHS 2590 (Rev. 4/06), documentation must be provided with the Progress Report for the third year of the award showing that the awardee has submitted a competitive research grant (or equivalent) for funding. This documentation should minimally be a copy of the face page of the application with all required institutional signatures.

An award can be terminated prior to the end of the third year by the NCI if the candidate does not submit an R01 type grant application or equivalent for peer review before the end of the second year (refer to Section IV.5. Funding Restrictions).

Evaluation

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

Progress Report

A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation

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

Belinda Locke, M.S.
Diversity Training Branch
Center to Reduce Cancer Health Disparities
National Cancer Institute
6116 Executive Boulevard, Suite 602, MSC 8341
Bethesda, MD 20892-8341 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-7344
Fax: (301) 402-4551
Email: lockeb@mail.nih.gov

2. Peer Review Contacts:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contacts:

Ms. Kimery B. Griffin
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3196
Fax: (301) 496-8601
Email: griffink@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:
Go to 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); and 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. (See the NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html.)

Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (see the NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998, at http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Clinical trials supported or performed by NCI require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the Principal Investigator/project manager or NCI program staff or a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB).

For details about the Policy for the NCI for Data and Safety Monitoring of Clinical trials, see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. For additional information, see NIH Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I and II Trials" at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available at http://www.cancer.gov/clinical_trials/.

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. (See http://grants.nih.gov/grants/policy/data_sharing.)

Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html). 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 at 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 that is available at 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 (see 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.

Public 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 PA 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.

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 FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended by Public Law 99-158 (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 2 years to the research. For further information, please see: http://www.lrp.nih.gov/.