Expired PA-08-151: Midcareer Investigator Award in Patient-Oriented Research (K24)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

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.nci.nih.gov/)
National Eye Institute (NEI) (http://www.nei.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/)
National Institute on Aging (NIA) (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (http://www.niams.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov/)
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR) (http://ninr.nih.gov/ninr/)
National Center for Complementary and Alternative Medicine (NCCAM) (http://www.nccam.nih.gov/)
Office of Dietary Supplements (ODS), (http://ods.od.nih.gov)

Title: Midcareer Investigator Award in Patient-Oriented Research (K24)

Announcement Type
This is a reissue of PA-04-107, which was previously released June 8, 2004.

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

December 12, 2008 - This PA has been reissued as (PA-09-037).
September 18, 2008 - See Notice (NOT-MH-08-017) NIMH Policy Update for Career Awards.
September 17, 2008 - See Notice (NOT-DA-08-039) NIDA is removing this salary cap and providing the maximum salary allowable.

Looking Ahead: As part of the Department of Health and Human Services' implementation of e-Government 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. For general information on this transition, please see the electronic submission website at http://era.nih.gov/ElectronicReceipt/ and the transition timeline at http://era.nih.gov/ElectronicReceipt/files/Electronic_Receipt_Timeline_Ext.pdf. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PA-08-151

Catalog of Federal Domestic Assistance Number(s)
93.866, 93.271, 93.855, 93.856, 93.846, 93.286, 93.398, 93.865, 93.173, 93.121, 93.847, 93.848, 93.849, 93.279, 93.113, 93.114, 93.115, 93.361, 93.867, 93.233, 93.837, 93.838, 93.839, 93.281, 93.853, 93.213, 93.389

Key Dates
Release Date: April 18, 2008
Letters Of Intent Receipt Date(s): Not applicable
Application Receipt Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS for guidance on dates.
Additional Information: To Be Available (URL Activation Date): Not applicable
Expiration Date: January 8, 2009 (per PA-09-037) - Originally: May 8, 2011

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The goals of NIH-supported career development programs are to help ensure that diverse pools of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation's biomedical, behavioral, and clinical research needs.

Purpose: The purpose of the Midcareer Investigator Award in Patient-Oriented Research is to provide support to mid-career health-professional doctorates or equivalent who are typically at the Associate Professor level or the equivalent (see Section III. Eligible Individuals) for protected time to devote to patient-oriented research (POR) and to act as research mentors primarily for clinical residents, clinical fellows and/or junior clinical faculty. The intent of this award is two-fold: 1) to enable mid-career clinician scientists to devote more time and to augment their capabilities in patient-oriented research; and 2) to enable mid-career clinical scientists to mentor new clinical investigators in the conduct of patient-oriented research. An award recipient who continues to have an independent peer-reviewed patient-oriented research program and continues to provide mentoring to new investigators can continue to contribute to the overall goals of the program after being promoted to Full professor.
Mechanism of Support: This Funding Opportunity Announcement (FOA) will utilize the NIH Midcareer Investigator Award in Patient-Oriented Research (K24) grant mechanism. Candidates must commit 3-6 person months (equivalent to 25 to 50% effort) to conducting patient-oriented research and mentoring.
Funds Available and Anticipated Number of Awards: The total amount to be awarded and the number of anticipated K24 awards will depend upon the quality, duration, and costs of the applications received as determined by the peer review process, available funds and program priorities. Applicant is strongly advised to contact the relevant IC for any distinct guidelines and other requirements (see Section VII. Agency Contacts).
Budget and Project Period: Applicants may request three to five years of support (at least three years are required).
Eligible Institutions/Organizations: Institutions/organizations listed in Section III.1.A. are eligible to apply.
Eligible Project Director/Principal Investigator (PD/PI): Only U.S. citizens or noncitizen 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 to receive this award. Candidates must meet this criterion prior to the time of award. Noncitizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. In addition to these requirements, the K24 applicant must have a health-professional doctoral degree or its equivalent. Applicants should typically be at the Associate Professor level or equivalent non-academic setting and must have an established record of independent, peer-reviewed patient-oriented research grant funding including at the time of application for this award, and record of publications.
Number of Applications: Candidates for the K24 award may not have pending or concurrently apply for any other PHS career award.
Resubmissions: Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). An applicant who gets promoted to the Full professor level will continue to be eligible for the purposes of resubmission.
Renewals: The K24 award may be renewed one-time for an additional three to five years of support if the award recipient continues to have independent peer-reviewed patient-oriented research support at the time of submission of the renewal application. Applicants requesting renewals must also meet all the remaining requirements of the original award and clearly demonstrate their continuing need for protected time to expand their research and mentoring programs.
Special Note: The participating NIH Institutes and Centers (ICs) may have different guidelines and requirements for this announcement in order to accommodate the career needs of researchers working in fields related to their specific missions. Candidates are therefore strongly encouraged to contact the staff person in the relevant Institute or Center listed in Section VII prior to preparing an application to discuss issues of eligibility and to review the specific provisions of this award (Table for IC contact information).
Application Materials: See Section IV.1 for application materials.
General Information: For general information on PHS 398 Application, see this Web sites: http://oerwebdev.od.nih.gov/grants/funding/phs398/phs398.html.
Hearing Impaired: Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

Table of Contents

Part I. Overview Information

Part II. Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Career Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. 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 and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Career Objectives

This Funding Opportunity Announcement (FOA) is a continuation of the Midcareer Investigator Award in Patient-Oriented Research program last issued in 2004 (PA-04-107), and the reader is referred to the previous FOA for historical information. The specific objectives of the Midcareer Investigator Award in Patient-Oriented Research (POR) are to enable mid-career clinician scientists to: 1) devote more time to and to augment their capabilities in patient-oriented research; and 2) to mentor new clinical investigators in the conduct of patient-oriented research. The K24 award is intended to provide protected time to mid-career clinical investigators who are typically at the Associate Professor level or the equivalent (see Section III. Eligible Individuals) and who have their own independent research support, i.e. PI s, to mentor junior clinical investigators, particularly K23 grantees, in POR and to stabilize the careers of these investigators so that they could continue to be available as mentors in POR. This award has formed an important part of the NIH initiative to attract and retain talented individuals to the challenges of patient-oriented research. The overall goal is to increase the pool of clinical researchers who can conduct patient-oriented research, who will be able to successfully compete for peer-reviewed grants, and who will mentor the next generation of clinical investigators.

It is expected that K24 recipients will obtain new or additional independent peer-reviewed funding as the PI for POR and establish and assume leadership roles in collaborative POR programs. In addition, it is expected that there will be an increased effort and commitment to mentor beginning clinician investigators in POR to enhance the research productivity of both the K24 investigator and increase the pool of well-trained clinical researchers of the future.

For the purposes of this award, patient-oriented research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator directly interacts with human subjects. This area of research includes: 1) mechanisms of human disease; 2) therapeutic interventions; 3) clinical trials, and; 4) the development of new technologies. Studies falling under Exemption 4 for human subjects research are not included in this definition.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity announcement (FOA) will use the NIH K24 award mechanism. Planning, direction, and execution of the proposed project and program will be the responsibility of the applicant.

This FOA uses the just-in-time budget concepts. However, since it requires that the applicant have a track record of research support, independent or otherwise, current, past, and pending research support must be documented in the application as part of the research support section of the biosketch. 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). The applicant should follow the instructions for budget information described in the PHS 398 instructions for Career Development Awards providing only the total direct costs for each year and the entire proposed period of support and budget justification information.

Applicants may request three to five years of support (at least three years are required). Funding beyond the first year is contingent upon satisfactory progress during the preceding year, as documented in the required progress report (refer to Section VI. 3. Reporting). The terms of the NIH Grants Policy Statement and the requirements of this FOA apply to these awards.

2. Funds Available

Because the nature and scope of the proposed research career development program will vary from application to application and the amounts provided by the participating ICs are not uniform, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Awards include funds for salary, fringe benefits, and research development costs.

The total amount to be awarded by the participating Institutes and Centers (ICs) and the number of awards will depend upon the quality and merit of applications received and the availability of funds.

2.A. Allowable Costs

Salary: The NIH Midcareer Investigator Award in Patient-Oriented Research (K24) will provide salary for levels of effort between 3-6 person months (or 25 and 50 percent effort). The actual salary provided by the award is based on a full-time, 12-month staff appointment at the sponsoring institution, the PIs institutional salary, and the level of effort requested, up to the maximum legislated salary rate in effect at the time of award (for FY 2008, see: NOT-OD-08-035). In all cases, the salary requested 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. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. Fringe benefits, based on the sponsoring institution’s rate and the percent of effort, are provided in addition to salary.

The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K24 award.

In addition, the candidate may derive additional compensation for effort associated with other Federal sources or awards provided the total salary derived from all Federal sources does not exceed the maximum legislated salary rate and the total percent effort does not exceed 100 percent.

Research Development Support: The NIH will provide up to $50,000 per year for the following expenses: (a) research expenses, such as supplies, equipment and technical personnel for the PI and the mentees; (b) travel to research meetings or training; (c) statistical services including personnel and computer time.

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

Recurring costs in future years: No yearly escalation for recurring costs will be provided.

Facilities and Administrative (F&A) Costs: These costs, which were formerly called indirect costs, will be reimbursed at 8% of modified total direct costs, exclusive of tuition and fees, and expenditures for equipment.

Section III. Eligibility information

1. Eligible Applicants

1.A. Eligible Institutions

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

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Small Businesses
For-Profit Organizations (Other than Small Businesses)

Foreign institutions are not eligible to apply.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research and mentoring activities is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are further encouraged to apply for NIH support. The following additional eligibility requirements apply:

Citizenship and Residency: 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 to receive this award. Candidates must meet this criterion prior to the time of award. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible.

Degree and Research: Candidates for this award must have a health-professional doctoral degree or its equivalent. Such degrees include but are not limited to the M.D., D.O., D.D.S., D.M.D., O.D., D.C., Pharm.D., N.D. (Doctor of Naturopathy), as well as a doctoral degree in nursing. Candidates with Ph.D. degrees are eligible for this award if the degree is in a clinical field or they perform patient-oriented research (POR). This may include clinical psychologists, clinical geneticists, speech and language pathologists.

Career Level: Applicants should typically be at the Associate Professor level or functioning at that rank in an academic setting or equivalent non-academic setting and must have an established record of independent, peer-reviewed patient-oriented research grant funding including at the time of application and record of publications. This award is intended for individuals who are at a mid-career stage and have a record of supervising and mentoring patient-oriented researchers. Candidates are advised to discuss their eligibility with the Institute or Center contacts listed in the Section VII (Table for IC contact information) of this program announcement.

Effort and Other Support: Candidates must be able to demonstrate the need for protected time, 25-50% of full-time professional effort (equivalent to 3-6 person months) for a period of intensive research focus as a means of augmenting their capabilities in patient-oriented research and mentor new clinical investigators in the conduct of patient-oriented research during this period. Awardees must commit 25-50% effort (equivalent to 3-6 person months) to conducting patient-oriented research and mentoring. Candidates for the K24 award may not have pending or concurrently apply for any other PHS career award.

Renewals: K24 awardees may apply for a one-time renewal for an additional three to five years of support if the K24 recipient continues to have independent peer-reviewed patient-oriented research support at the time of submission of the renewal application. Applicants should clearly demonstrate their continuing need for protected time to expand their research and mentoring programs. During the course of the initial award, an investigator may be promoted from Associate Professor to Full Professor. Such investigators are considered to be eligible to apply for renewal of their support, as long as they meet all other eligibility requirements stated in this FOA. Renewal K24 applications will not be rejected, nor will they be unscored, solely based on the applicant’s academic rank. Reviewers will continue to apply their professional judgment in assessing the five review criteria, and in assigning priority scores to specific K24 grant applications. Individual NIH Institutes and Centers may differ in the programmatic priority that they apply to investigator rank in reaching their funding decisions. Differences in the rates of investigator promotion may mean that a Full Professor may or may not be considered mid-career depending on the discipline.

Note: 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 NIH loan repayment program (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: www.lrp.nih.gov.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

The following special eligibility requirements apply:

Program: The K24 award provides three to five years of support. 3-6 person months (25-50% of full-time professional effort) must be devoted to the patient-oriented research program and mentoring that are part of the award. The remainder may be devoted to other clinical, teaching, or research pursuits consonant with the objectives of the award.

PI status: A K24 recipient who is promoted to a higher academic position (viz., Full Professor or equivalent) during the award and continues to have an independent peer-reviewed patient-oriented research program and continues to provide mentoring to new investigators can retain the award and remain eligible to apply for a renewal.

Research Support: Candidates are expected to continue to hold independent peer-reviewed support for POR during the period of this award. Candidates losing this support during the award period must document in their annual Progress Reports efforts to replace this support and demonstrate that they continue to meet all other requirements of the K24 award. Candidates may not receive additional compensation from another HHS award (specifically, AHRQ or SAMHSA) that exceeds the maximum allowable salary compensation (See details on current salary limitations at http://grants.nih.gov/grants/policy/salcap_summary.htm).

Environment: The institution must be able to demonstrate a commitment to the applicant as a productive, independent investigator. The application must describe a program that will use the relevant research and educational resources and facilities available. The institution must certify that the candidate will be released from other duties and be able to devote 25 to 50 percent effort (at least 25 percent effort) to a patient-oriented research program. The applicant institution must document the availability of beginning clinical investigators (including junior clinical faculty) to be mentored. In addition, if there is an NIH institutional career development award (K12); an NIH Clinical Translational Science Award (CTSA) with an institutional career development component; or an NIH Clinical Research Curriculum Award (K30) at the sponsoring institution, a plan should be described for integrating the proposed K24 mentoring activities with activities under these programs.

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: [email protected].

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 and 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.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

See also Section VI.2. for additional information.

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 Receipt Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm

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 PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and five 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 NOT-OD-03-040).

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. Upon receipt, applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. 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.

Citizenship: Applicants must meet the citizenship requirements as described in the Eligibility section of this announcement prior to award (Section III).

Concurrent Awards: Applicant must be aware of the NIH policies associated with other federally sponsored support.

Pre-Award Costs: 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 K24 initial budget period of a new or renewal 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 or renewal award.

The incurrence of pre-award costs in anticipation of a or non- 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

Supplementary Instructions: The research career development award instructions in the Form PHS 398 do not fully apply to the special need of this midcareer investigator award grant program (K24). Letters of Reference, information about the Career Development/Training Activities During Award Period, and Statements by Sponsor(s) are NOT REQUIRED. Therefore, in addition to the required information listed in the instructions for Research Career Awards in the PHS 398, all applications MUST include the following information in the respective sections:

Biographical Sketch: A biographical sketch should be provided only for the candidate using the Biographical Sketch Format Page. Candidates must list current, past, and pending research support following the format of the BIOGRAPHICAL SKETCH Format Page in the PHS Form 398 format and clearly define their specific role on each of the listed research projects/ grants. For renewal K24 applications, identify those research projects resulting directly from the support provided by the prior K24 award.

Candidate: (1) Provide details of the candidate’s immediate and long-term career objectives in POR and in mentoring new clinician investigators. (2) Include a summary of the research career of the candidate, documenting the ability of the candidate to conduct high quality POR and commitment to a career in POR. (3) Document of the ability of the K24 applicant to provide mentoring to new clinician investigators. Provide the number of years of mentoring experience, mentoring role (i.e., research advisor, clinical mentor, etc.), the number of clinicians mentored, the specialties of the individual mentees and the stages in their professional career. In addition, describe the types of research that were conducted by the individuals mentored, and the proportion of mentored individuals currently in academic medicine and/or directly participating in POR. (4) Provide an explanation as to how relief from patient care or administrative responsibilities through the protected time provided by this award will contribute to the development or expansion of the candidate’s POR program and increased level of commitment to mentoring beginning clinician investigators. It is important to convey to the reviewers the reasons for needing protected time to continue a vital research program and continue to engage in the mentoring of new scientists. It should be clear that this award will permit the candidate to spend more time on research and mentoring and less time on administrative and clinical responsibilities for the institution.

Environment and Institutional Commitment to the Candidate: (1) Include a description of the facilities and other resources that will be provided to the candidate. (2) The letter of commitment from the institution should provide statements concerning the amount of protected time the candidate will receive (25 to 50% required); the duties from which he/she will be relieved (if clinical duties the institution should describe specific steps that will be taken to cover these duties, such as hiring clinical staff); and the institutional commitment to enhancing the candidate's ability to be a productive, independent investigator. Descriptions of the institution should be sufficiently detailed so that reviewers can determine if the environment is conducive to performing high quality POR. This information will be evaluated very carefully by the peer reviewers and carry substantial weight in the evaluation of an application.

Research Plan: Provide a Research Plan that establishes goals both for the individual’s research career and for mentoring. These goals should be appropriate to the experience level of the candidate, and to the research and training environment. The Research Plan should be presented in two separate parts, and indicate the percent effort committed to the entire research plan:

Currently supported research: There is no need to provide extensive detail with regard to ongoing, funded research. Enough information should, however, be provided in the areas of Hypotheses and Specific Aims; Background, Significance and Rationale; Preliminary Studies and Results; and Research Design and Methods to permit the peer reviewers to evaluate the extent, special features and general quality of the candidate's research activities and opportunities for mentoring.
New research to be specifically supported by this grant: Describe how this award will be used to help augment the candidate’s research skills and/or develop new directions in POR. This description should include a Statement of Hypothesis and Specific Aims; Background, Preliminary Studies and Aims; Significance and Rationale; and Research Design and Methods. Although it is not expected that this description would be as detailed as an application for an investigator-initiated research grant (e.g., R01), it is expected that sufficient detail be provided to permit an evaluation of the scientific merit of the research, and to clearly show research opportunities for mentoring. Documentation must be provided that appropriate and adequate resources, both in terms of support and facilities, are available to the candidate to conduct the research program(s). This is an important part of the application because it will provide the main rationale and justification needing protected time for research. The candidate must ensure that the inclusion of women, members of minority groups and their subpopulations, and children, has been addressed in the development of the design for all proposed patient-oriented research. The candidate must provide for each new research project proposed the information described in the General Instructions in Form PHS 398 on Human Subjects and Vertebrate Animals. Candidates must provide plans for ensuring continuing support of their POR programs preferably with them as the PI.

Plan to Provide Mentoring: A plan to provide mentoring is a required component of the application. The plan should include a description of the availability of new clinician investigators for mentoring; their previous training and specialization; plans for recruitment, selection and supervision; the types of educational and research experiences that will be provided; and the capacity in which the candidate for the K24 award will serve as a mentor. If there is an existing clinical research curriculum, e.g. an NIH K30, describe how the mentoring plan will be integrated with the curriculum. Candidates must also describe a plan for supporting the research of their mentees during the period of the K24 award. This plan should include active support for POR at the time of application for a K24 Award, and may include K24 Research Development Support. Applicants must indicate the proposed percent effort committed to the mentoring plan.

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 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 web site http://www.nih.gov/sigs/bioethics/researchethics.html for additional guidance. In addition, applications must 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.

Budget: The budget request must be provided according to the instructions in form PHS 398 following information included in this FOA. The request for research support costs, including any tuition and fees, travel, etc., must be justified and specified by category.

Appendix materials: All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application. Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix (see: NOT-OD-08-031).

Do not use appendix to circumvent the page limitations of the Research Plan. An application that does not observe the relevant policies and procedures may be delayed in the review process or considered as non-responsive.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Not applicable.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information

1. Criteria (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 the Institutes and Centers (ICs) on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

As part of the initial merit review, all applications:

May 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.
Will receive a written critique
Will receive a second level of review by an appropriate national advisory council or board.

Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

Scientific merit and quality of the proposed applications as determined by peer review.
Relevance to program priorities of the appropriate IC.
Availability of funds.

The scientific review group will address and consider each of these criteria in assigning the application s overall score. The application does not need to be strong in all categories to receive a high priority score. The review criteria are listed in logical order, not in order of priority.

Candidate:

Is there evidence of ongoing high quality patient-oriented research, and what is the relationship of that research to this K24 proposal?
Is there evidence of the candidate's capabilities and commitment to serve as a mentor for new clinical investigators in the conduct of patient-oriented research?
Does the application demonstrate that the proposed program and protected time will relieve the candidate from non-research patient care and administrative duties and allow him/her to devote additional time and to augment his/her capabilities in patient-oriented research?
Does the application demonstrate a record of independent peer-reviewed support for patient-oriented research that is likely to continue during the K24 award?

Research Plan:

Although it is understood that currently funded research described in K24 applications do not require the level of detail necessary in regular research grant applications, a fundamentally sound research plan must be provided. Research proposed in the K24 application that is not currently funded by a peer-reviewed grant should include a Statement of Hypothesis and Specific Aims; Background, Preliminary Studies and Aims. In addition, the application should outline the general goals for the later years and sufficient detail should be provided to permit evaluation of the scientific merit of the plan.

Is the research plan an appropriate vehicle for demonstrating and developing the prospective mentee’s skills and capabilities in patient-oriented research?
Are the scientific and technical plans of the proposed research of merit?
Is the proposed research relevant to the candidate's career objectives?
Are adequate resources available to conduct the research program? This includes adequacy of plans for continued support of the research during the funding period of the grant.
Is the plan's attention to gender and minority issues associated with projects involving human subjects adequate?
Are the plans for including children appropriate for the scientific goals of the research, or is the justification for their exclusion adequate?

Plan to Provide Mentoring:

Are the plans for mentoring or supervising new clinical investigators in patient oriented research adequate?
Are plans to integrate appropriate clinical research curricula, such as those offered by available K30 programs at the institution, into the mentoring plans adequate?
Is an appropriate level of effort proposed for the mentoring component?

Progress Assessment (Additional criteria for renewal applications):

To what extent have the career, research and mentoring objectives of the previous award period been achieved?
Is the justification for an additional 3 to 5 years of support adequate? (This requires that the recipient continue to have independent peer-reviewed patient-oriented research support at the time of submission of the renewal application).
Does the PI adequately demonstrate the continuing need for protected time to expand his/her research and mentoring program?
Is there evidence of the PI’s leadership in patient-oriented research such as through being principal investigator on independent peer-reviewed research grants and providing high quality mentorship?

Environment and Institutional Commitment:

What is the applicant institution's commitment to the scientific development of the candidate and has the institution provided assurances that they intend the candidate to be an integral part of its patient-oriented research program?
Are adequate research facilities and resources, and appropriate educational opportunities available to the candidate?
What is the quality and relevance of the environment for continuing the scientific and professional development of the candidate and for others pursuing patient-oriented research?
What is the applicant institution's commitment to provide adequate protected time for the candidate to conduct the research and mentoring program?
What is the applicant institution’s commitment to the career development in patient-oriented research of new clinical investigators mentored by the candidate?

Training in the Responsible Conduct of Research:

Is the proposed training in the responsible conduct of research appropriate and adequate?

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:

Resubmission Applications: Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section 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 career development plan and proposed research.

2.C. Resource Sharing Plan(s)

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

Data Sharing Plan. Not Applicable.
Sharing Model Organisms. [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html]
Genome Wide Association Studies (GWAS). [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html]

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated 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.

2. Administrative and National Policy Requirements

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

The following related administrative policies apply to NIH Research Career Award ( K ) programs:

A. Evaluation: In carrying out its stewardship of human resource-related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, 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.

B. 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 NIH awarding component.

C. Special Leave: Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval of the NIH awarding institute or center is required. Details on the process for submission of prior approval requests can be founds in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600130).

Due to the special nature of the K24, this letter must include a description of the plans to continue meeting the effort commitments of both the research and mentoring components of the K24 award. 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 K24 award will continue during such leave.

Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH component institute and will be granted only in unusual situations.

Support from other sources is permissible during the period of leave without award support. Such leave does not reduce the total number of months of program support for which an individual is eligible.

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

If the grantee is moving to another eligible institution, career award support may be continued provided:

A relinquishing statement is submitted by the original institution and a transfer application is submitted by the new institution at least three months prior to the transfer in order to allow the necessary time for administrative review by the NIH awarding institute.
All conditions of the award are met at the new institution.
The period of support requested is no more than the time remaining within the existing award period.
A change of grantee request normally will be permitted only when all of the benefits attributable to the original grant can be transferred, including equipment purchased in whole or in part with grant funds. In reviewing a request to transfer a grant, NIH will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project. A change may be made without peer review, provided the PI plans no significant change in research and career development objectives and the facilities and resources at the new organization will allow for successful performance of the project. If these conditions or other programmatic or administrative requirements are not met, the NIH awarding office may require peer review or may disapprove the request and, if appropriate, terminate the award.

If an applicant is planning to move to a new eligible institution prior to or immediately after the issuance of an award, the individuals listed in Section VII of this program announcement should be contacted prior to the preparation of an application to discuss this situation.

A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or when an award is relinquished as a recipient changes institutions.

3. Reporting

Awardees will be required to submit the PHS Non- Grant Progress Report, Form 2590 annually: Note that the instructions for Research Career Development applications must be followed for this program http://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the NIH Grants Policy Statement.

The Progress Report must include all the appropriate sections as described in the general PHS form 2590 instructions.

Additional reporting requirements: (for non- and renewal applications)

A description of how the K24 award has contributed to the recipient’s immediate and long-term career objectives.
Updated listing of active and pending research support using the OTHER SUPPORT pages from PHS Form 398. Clearly denote the recipient’s role in each of these grants or projects. Asterisk those active/pending sources of support that are a result of the protected time provided by the K24 award. Describe plans for obtaining patient-oriented research support during the next funding period.
A description of the research activities conducted during the reporting period. This description should clearly distinguish research activities utilizing the protected time provided by the K24 award from other research activities.
A description of the mentoring activities during the prior award period directly resulting from the protected time provided by the K24 award. Include the names of the individuals mentored; degree(s), professional specialty(ies) and staff positions; publications resulting directly from the K24-supported mentoring; current positions; and mentoring activities for each of these individuals. Describe plans for mentoring new clinical investigators during the next funding period.

A final progress report, inventions statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Applicants should refer to the NIH Web site (Table for IC contact information) for information regarding each IC's scientific/research contacts for this K24 program.

2. Peer Review Contacts:
Not applicable.

3. Financial or Grants Management Contacts:

Applicants should refer to the NIH Web site (Table for IC contact information) for information regarding each IC's grants management contact for this K24 program.

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

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

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

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.

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 public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html), investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. 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: (Be sure to cite any additional appropriate authorizations, regulations or policies below)
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/.