Part I Overview Information

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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/)

Title: Cancer Prevention, Control, Behavioral, and Population Sciences Career Development Award (K07)

Announcement Type
This is a reissue of PAR-06-381.

Update: The following updates relating to this announcement have been issued:

• December 22, 2011 - This PAR has been reissued as PAR-12-067.
• January 20, 2011 - Please see NOT-OD-11-036 informing applicants that the Letters of Reference are due by the application receipt deadline date.
• September 29, 2010 (NOT-OD-11-008) - Updated Electronic Application Forms Required for F, K, T and D Submissions with Due Dates of January 25, 2011 and Beyond. Adobe B1 forms are required for due dates on or after January 25, 2011.
• June 24, 2010 - See Notice NOT-TW-10-008 Notice to Highlight Current NIH Funding Opportunities that Promote Research on the Human Health Effects of Climate Change.
• December 30, 2009 - This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative. The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond. If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the Adobe-Forms-B version of the application forms and instructions. If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the Adobe-Forms-A version of the application forms and instructions.
• April 2, 2009 - Change in allowable salary levels on Career Awards supported by the National Cancer Institute (see Notice NOT-CA-09-022).
• February 9, 2009 - See Notice (NOT-CA-09-013) The National Cancer Institute (NCI) is announcing a change in allowable levels of salary support .

Program Announcement (PA) Number: PAR-09-078

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

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

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

Catalog of Federal Domestic Assistance Number(s)
93.398, 93.866, 93.272, 93.213

Key Dates
Release/Posted Date: January 15, 2009
Opening Date: January 15, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not applicable
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable.
Expiration Date: January 8, 2012

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The overall goal of NIH-supported career development programs are to help ensure that a diverse pool 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 NCI Cancer Prevention, Control, Behavioral and Population Sciences Career Development Award is to provide support for salary and research costs for up to 5 years for individuals with health professional or science doctoral degrees who are not fully established investigators and who want to pursue research careers in the cancer prevention, control, population, and/or behavioral sciences. The primary objective of this program is to increase the number of investigators who have made commitments to focus their research endeavors on cancer prevention, control, behavioral, and the population sciences.
• Mechanism of Support: This Funding Opportunity Announcement (FOA) will utilize the NIH Academic Career Award (K07) mechanism. Candidates must commit a minimum of 9 person months (75%) effort to activities covered under the award.
• Funds Available and Anticipated Number of Awards: The total amount to be awarded by the participating ICs and the number of awards will depend upon the quality and merit of applications received and the availability of funds.
• Budget and Project Period: Because the nature and scope of the proposed K07 award 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 ICs 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. Applicants may request up to five years of support.
• PHS 398 Career Development Award Supplemental Form Component Sections: Candidate's Background, Career Goals and Objectives, Career Development/Training Activities During Award Period, and Training in the Responsible Conduct of Research and Research Strategy are limited to a combined total of 12 pages.
• Eligible Institutions/Organizations: Institutions/organizations listed in Section III are eligible to apply.
• Eligible Project Director/Principal Investigator (PD/PI): Also referred to as the Applicant or Candidate, individuals with the skills, knowledge, and resources necessary to carry out the proposed research and career activities are invited to with their mentor (if applicable) and sponsoring institution to develop an application for support. They must have a health professional or science doctoral degree and be: 1) already proficient in general epidemiology, behavioral sciences, or other relevant disciplines, and now want to make use of these proficiencies in cancer-focused research careers in prevention, control, population and/or the behavioral sciences; or 2) already trained in cancer epidemiology, etiology, prevention, control, and the behavioral and population sciences, but are not yet fully independent investigators. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are always encouraged to apply for NIH support. Applicants must be U.S. citizens, non-citizen nationals, or permanent residents, who hold a research or health-professional doctoral degree and can commit the minimum required effort to relevant career activities. See Section III.
• Number of PDs/PIs: Only one PD/PI may be designated on the application.
• Number of Applications. Applicants may only have one individual Career Award application pending peer review at any time.
• Resubmissions: See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
• Renewals: K07 awards are not renewable and are not transferable from one PD/PI to another.
• Special Date(s): This FOA uses standard due dates.
• Application Materials: See Section IV for application materials.
• General Information: For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
  • SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
  • General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Hearing Impaired: Telecommunications for the hearing impaired are available at: TTY 301-451-5936.

Table of Contents

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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 of Support
2. Funds Available

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

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically 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 Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

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Section I. Funding Opportunity Description

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1. Research Career Objectives

Background

Recognizing a need for training researchers in preventive oncology and the lack of multidisciplinary curricula that would be needed for this purpose, the National Cancer Institute (NCI) published in 1982 the announcement titled "Preventive Oncology Academic Award" (POAA; NIH Guide for Grants and Contracts, Vol. 11, No. 5, April 23, 1982). The POAA provided support for the development of institutional preventive oncology curricula focused specifically on etiologic studies and primary prevention of cancer. In 1985, the NCI made two significant changes in that award. First, the emphasis on support for institutional curriculum development was changed to support of research and career development of individuals who wanted to make a transition to cancer prevention and control research and to individuals already trained in cancer prevention and control who were not yet fully independent investigators. Second, the original focus on cancer etiology and primary cancer prevention was expanded to include all cancer prevention and control sciences and technologies from hypothesis development through demonstration.

In 1998, the National Cancer Institute completed major external reviews of its programs in cancer prevention and control sciences. The scientific experts who conducted these reviews identified the current level of support for training in cancer prevention and cancer control and the single discipline emphasis of these programs as being completely inadequate to take advantage of the new opportunities for reducing cancer incidence, morbidity, and mortality. These experts recommended that the NCI increase its current level of support of education/training programs in cancer prevention and cancer control and generate new opportunities for multidisciplinary training in these disciplines of basic and clinical scientists in highly interdisciplinary and collaborative environments. Similar recommendations regarding training opportunities in cancer prevention and control have been made by other NCI advisory groups. In 1999, the NCI published a new K07 FOA incorporating the recommendations made by these experts.

Objectives

The objective of this initiative is to continue NCI support for specialized didactic study and mentored research in scientific areas relevant to cancer prevention, cancer control, and behavioral and population sciences research. Individuals lacking skills in data management, statistics, epidemiology, study design, clinical trial design, hypothesis development, etc., can be provided the opportunity to participate in courses designed to overcome these deficiencies. The scope of the research and didactic training may extend from the development and experimental testing of hypotheses including chemoprevention trials, through the stage of confirming results using defined populations, to the development and demonstration of technology as applied to epidemiology, cancer prevention, cancer control, and the behavioral and population sciences as they relate to cancer. This FOA is a re-issuance of PAR-04-055 (http://grants1.nih.gov/grants/guide/pa-files/PAR-04-055.html).

Examples of relevant disciplines and research areas for this Funding Opportunity Announcement (FOA) include:

• any aspect of research on the prevention of human cancers (e.g., modifiable risk factors; basic prevention sciences);
• research including new animal models pertinent to cancer prevention and extrapolation of this research to human cancer,
• human cancer genetics, genetic predisposition to cancer, and detection of precursor lesions;
• patient-oriented research focused on cancer prevention;
• behavioral research and behavioral intervention trials in cancer prevention,
• cancer epidemiology (biochemical, genetic, molecular epidemiologic studies), cancer epidemiology-related biostatistics;
• clinical oncology; and
• human nutrition, behavioral and social sciences, health promotion, health services and health policy research; and medical decision analysis, survivorship and quality of life as they relate to cancer.

For the purpose of this FOA, cancer control research is defined as "basic and applied research in the behavioral sciences that independently or in combination with biomedical approaches, reduces cancer risk, incidence, morbidity, and mortality across the lifespan and over the entire process of carcinogenesis from primary behavioral prevention in youth, to screening, treatment, and survivorship" (Report of the NCI Cancer Control Progress Review Group, 1998). Additionally, 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.

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

Section II. Award Information

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1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the NIH Academic Career Award (K07) mechanism. The Project Director/Principal Investigator (PD/PI) (also referred to as the Applicant or Candidate) and his/her mentor (if applicable) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses non-modular budget format.

The applicant should follow the instructions for budget information described in Section IV Other Submission Requirements as well as in PHS 398 Career Development Award Supplemental form Section 7.4.6 of the R&R 424 instructions providing only the total direct costs for each year and for the entire proposed period of support and budget justification information.

This K07 career development award provides up to 5 years (a minimum of 3 years is required) of salary and research support for more junior investigators who are interested in developing academic and research expertise in a particular health-related field, as a way to increase the overall pool of individuals capable of research or teaching in the identified area. During the period of the award, the candidate will become a successful academic researcher in the chosen area. Research, teaching, and leadership skills are to be learned during the tenure of the award. Curriculum building skills are encouraged. A mentor is required. A minimum of 9 person months (75%) of full-time professional effort is required annually; the remainder may be devoted to other research related and/or teaching pursuits consonant with the objectives of the award.

The K07 career development awards are not renewable nor are they transferable from one PD/PI to another. Under certain circumstances, this K07 award can be transferred to another institution.

2. Funds Available

Because the nature and scope of the proposed K07 award 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 ICs 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.

2.A. Allowable Costs

Salary: The NCI will provide salary and fringe benefits for the K07 award recipient. Direct costs are limited to up to $100,000 per annum salary. The total salary requested must be based on a full-time, 12-month staff appointment. The K07 career development award requires the candidate to devote a minimum of 9 person-months (75% of full-time professional effort) to conducting the research and developmental programs activities described in the application required for academic development. The remaining effort may be devoted to clinical, teaching, or other research pursuits and activities consistent with the objectives of the award. For information regarding NIH policy on determining full-time professional effort for career awards, see NOT-OD-04-056.

The salary 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. Confirmation of salary is required prior to the issuance of an award. Fringe benefits, based on the sponsoring institutions rate and the percent of effort, are provided in addition to the salary.

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 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 K07 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. See: http://grants.nih.gov/grants/policy/salcap_summary.htm.

K07 award recipients are encouraged to obtain funding from NIH or other Federal sources either as a named PD/PI on a competing research grant award or cooperative agreement or as sub-project director on a competing multi-project award (see NOT-OD-08-065). Within the last 2 years of the K07 award, the effort required on the K07 award may be reduced to no less than 6 person-months (50% full-time professional effort) at the grantee organization and replaced by effort from the research award so that the total level of research commitment remains at 9 person-months (75% full-time professional effort) or more for the duration of the K07 award. To be eligible for salary support from peer-reviewed research awards from any Federal agency:

• The K07 award recipient must be the PD/PI (or one of the named PD/PIs, if following the multiple-PI model) on a competing NIH research grant application (R01, R03, R15, R21, R34, or equivalent application from another Federal agency) or a sub-project director on a competing multi-component research or center grant or cooperative agreement application (P01, P50, U01, etc. or an equivalent application from another Federal agency).
• The K07 award must be active when the competing research grant application is submitted.
• The K07 award must be in its final two years before the reduction in effort to 6 person-months (50% full-time professional effort) is permitted.

Research Development Support: The NCI will provide up to $30,000 per annum for research development support for the K07 award recipient. These costs may be used for the following expenses: (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment, and technical personnel; c) travel to research meetings or training; and (d) statistical services including personnel and computer time.

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

Indirect Costs: These costs also known as Facilities and Administrative (F&A) costs, will be reimbursed at eight percent (8%) of modified total direct costs.

NIH Grants Policy: NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

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1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public/State Controlled Institution of Higher Education
• Private Institution of Higher Education
• Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
• Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
• For-Profit Organization (Other than Small Business)
• State Government
• U.S. Territory or Possession
• Indian/Native American Tribal Government (Federally Recognized)
• Indian/Native American Tribal Government (Other than Federally Recognized)
• Indian/Native American Tribally Designated Organization
• Hispanic-serving Institution
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Regional Organization
• Other(s): Faith-based or community based organizations

Foreign institutions are not eligible to apply.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Project Director/Principal Investigator (PD/PI): Also referred to as the Applicant or Candidate, individuals with the skills, knowledge, and resources necessary to carry out the proposed research and career development activities are invited to work with their mentor (if applicable) and sponsoring institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are always encouraged to apply for NIH support.

Citizenship and Residency: Only U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who have a currently valid Permanent Resident Card (USCIS Form I-551), or some other verification of legal admission as a permanent resident prior to the time of award, are eligible for this 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 clinical, research, or health-professional doctoral degree. Such degrees include but are not limited to the Ph.D., M.D., D.O., D.D.S., D.M.D., O.D., D.C., D.S.W., D.P.H., Pharm.D., N.D. (Doctor of Naturopathy), as well as a doctoral degree in nursing research or practice.

Level of Effort: Candidates for the K07 career development award must have a full-time appointment at the academic institution that is the applicant institution. Candidates who have VA appointments may not consider part of the VA effort towards satisfying the full-time requirement at the applicant institution (see: NOT-OD-04-056). Candidates with VA appointments should contact the staff person in the NCI prior to preparing an application to discuss their eligibility.

Candidates for a K07 career development award must be able to commit a minimum of 9 person months (75%) of full-time professional effort to conducting research career development and research activities associated with this award. The remaining 3 person months (25%) effort can be divided among other research, clinical and teaching activities only if these activities are in a fashion consistent with the goals of the K07 award, i.e., the candidate's development into an independent investigator.

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

Number of Applications: Candidates may only have one individual Career Development Award application pending peer review at any time.

Resubmission(s): See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).

Renewals: Awards are not renewable and are not transferable from one PD/PI to another.

K07 Career Development award:

• Former PD/PIs of NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) remain eligible for a Career Development award.
• Individuals are not eligible for a Career Development Award if: (1) they have been a PD/PI or have an application pending for any other PHS career award; or (2) if they are a current or former PD/PIs on NIH research project grants (e.g. R01), project leaders on sub-projects of program project (P01) or center (P50) grants; or (3) if they are PD/PI on an equivalent non-PHS peer-reviewed research grants that are over $100,000 direct costs per year.
• Candidates must be :1) already proficient in general epidemiology, behavioral sciences, or other relevant disciplines, and now want to make use of these proficiencies in cancer-focused research careers in prevention, control, population and/or the behavioral sciences; or 2) already trained in cancer epidemiology, etiology, prevention, control, and the behavioral and population sciences, but are not yet fully independent investigators.
• The sponsoring institution must provide a statement of commitment to the proposed level of effort required by this award.

Key elements and common aspects that will be considered for each application include:

• Mentor(s) (see below)
• Environment (see below)
• Institutional Commitment (both awards)
• Career Development Plan (K07 Development award)
• Curriculum Development Plan (K07 Leadership award)

3.A. Special Requirements

Application: Applications proposing a research career development experience in basic cancer prevention sciences must include a plan for translating the results of this research into human cancer prevention during the project period of the K07 award.

Career Development Plan: This award is supported by the NIH K07 Academic Career Award funding mechanism. Consequently, the career development plan must include a substantive academic (didactic) component.

Mentor(s): The candidate must name a primary sponsor/mentor, who together with the applicant is responsible for the planning, direction, and execution of the program. The mentor should be recognized as an accomplished investigator in the proposed program and have a track record of success in training similar investigators. The mentor should have sufficient independent support to cover the costs of the proposed project in excess of the allowable costs of this award. Candidates may also nominate co-mentors as appropriate to the goals of the program. Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.

Institutional Environment: The applicant institution must have a strong, well-established record of career development activities and faculty qualified in biomedical, behavioral, or clinical research to serve as mentors. The institution must have well-established research programs in basic, clinical and/or cancer prevention/control/behavioral/population sciences. This research environment should be one in which there are active research collaborations that exemplify a dynamic two-way exchange of information and ideas between laboratory and clinical and/or population research settings. The institution must demonstrate a commitment to the development of the candidate as a productive investigator and be willing to allow the protected time needed by the applicant. The candidate, mentor, and institution must describe a career development program that will maximize the use of this environment, including available facilities and resources.

Section IV. Application and Submission Information

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

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

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

• Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

The PD/PI should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

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

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

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email support@grants.gov

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email commons@od.nih.gov

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

• The individual designated as PD/PI on the application must be registered also in the NIH eRA Commons prior to the submission of the application.
• The PD/PI must hold a PD/PI account in the Commons. The applicant should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
• This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

The PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Several of the steps of the registration process could take four weeks or more. Therefore, the applicant should immediately check with his/her business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

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

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

For further assistance, contact GrantsInfo -- Telephone 301-710-0267, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

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

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

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
SF424 (R&R) Detailed Budget
PHS398 Cover Letter
PHS398 Cover Page Supplement
PHS398 Career Development Award Supplemental Form
PHS398 Checklist

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date:January 15, 2009 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): Not applicable
Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward

3.A.1. Letter of Intent

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

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

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

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

• If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
• If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or did not transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

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

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

The NIH will not accept any application in response to this FOA 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. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

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 (see Section III) at the time of award.

Concurrent Awards: Applicant must be aware of the NIH policies associated with other federally sponsored support (see: NOT-OD-08-065).

Salary Support: The salary requested for the candidate must be consistent with both the established salary structure for full-time staff appointments and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the applicable department.

NIH policy allows NIH mentored career development award recipients in the final two years of their award to receive salary support from both their K award and a research grant from any Federal agency (see NOT-OD-08-065). The K-award recipient must be a named PD/PI of a competing research project grant (R01, R03, R15, R21, R34, etc.), or be the sub-project director on a competing multi-component research or center grant or cooperative agreement (P01, P50, U01, etc.). See the Notice for full details.

Research Development Support: The research development support costs allowed for this program must be justified and be consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities. Salary for ancillary personnel support, such as mentors, secretarial and administrative assistants is not allowed.

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 initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

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

6. Other Submission Requirements and Information

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements (see http://grants.nih.gov/grants/funding/424/index.htm):

PD/PI Credential (e.g., Agency Login): The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

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

The following information must be included in the application in accordance with the Supplementary Instructions for Research Career Awards in the SF424 (R&R) Application Guide (See Part I.7.5).

PHS 398 Career Development Award Supplemental Form Component Sections: Candidate's Background, Career Goals and Objectives, Career Development/Training Activities During Award Period, and Training in the Responsible Conduct of Research and Research Strategy are limited to a combined total of 12 pages.

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Appendix Materials: Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.

6.A. K07 Award

6.A.1. Candidate Information and Career Development Plan

Candidates Background:

• Describe the candidate's commitment to a career as an academic investigator in cancer prevention, control; and the behavioral or population sciences as they relate to cancer prevention and control. This should include a description of all of the candidate's professional responsibilities in the grantee institution and elsewhere and their relationship to the proposed activities on the career award.
• Describe any prior training and how it relates to the immediate objectives and long-term career plans of the candidate.
• Describe the candidate's research efforts and training to this point in his/her research career, including any publications, prior research interests and experience; and how this effort relates to the objectives and long-term career plans of the candidate.
• Provide evidence of the candidate's ability to interact and collaborate with other scientists.
• Provide evidence of the candidate's potential to develop into an academic investigator.
• Provide a statement that the candidate will commit at least 9 person-months (75% of full-time professional effort) to the program and related career development activities. The mentor or department chair must agree and provide a statement in the application documenting that this percent of your time will be protected.

Career Goals and Objectives:

• A systematic plan that: (1) shows a logical progression from the candidates prior research and training experiences to the training and research experiences that will occur during the K07 career development award period and then to independent investigator status; (2) justifies the need for further career development to become an independent academic investigator; (3) includes didactic and research components; and (4) utilizes the relevant research and educational resources of the institution.

Career Development/Training Activities:

• Provide details and the duration of planned structured activities, such as coursework (including course numbers and descriptive titles), seminars or technical workshops, etc. essential to develop the necessary knowledge and research skills in scientific areas relevant to the candidates career goals.
• If there is a curriculum development component, describe how the results of the plan will contribute to an increase in the pool of individuals with academic or research expertise and/or enhance the educational or research capacity at the sponsoring institution.
• The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline including a publication plan is strongly encouraged. Although not required, an advisory committee may be formed to assist with the development of the program of study and to monitor the candidates progress through the career development program.
• Describe the relationship of the research plan to the career development plan.
• Describe the professional responsibilities/activities including other research projects beyond the minimum required 75% effort commitment to the career development Award. Explain how these responsibilities/activities will help ensure career progression to an independent research investigator.

Training in the Responsible Conduct of Research:

• Applications must include a plan to obtain instruction in the responsible conduct of research.
• This section should document prior instruction in responsible conduct of research during the applicant?s current career stage (including the date of last occurrence) and propose plans to receive instruction in responsible conduct of research
• Such plans must address five instructional components (format, subject matter, faculty participation, duration of instruction, and frequency of instruction), as outlined and explained in NOT-OD-10-019.
• The plan may include career stage-appropriate, individualized instruction or independent scholarly activities that will enhance the applicant?s understanding of ethical issues related to their specific research activities and the societal impact of that research.
• The role of the sponsor/mentor in responsible conduct of research instruction must be described.
• Applications lacking a plan for participation or instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process.

• The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019.

6.A.2. Research Plan

The research plan should follow instructions outlined in PHS 398 Career Development Award Supplemental form, including sections on Specific Aims, Significance, Preliminary Studies/Progress Report ( for New and Renewal/ Revision Applications, respectively), and Approach. The candidate should consult with the mentor(s) regarding the development of this section.

• A sound research project that is consistent with the candidates level of research development and objectives of his/her career development plan must be provided.
• Data and Safety Monitoring (when applicable): Individual NIH institutes may have specific requirements for data and safety monitoring of clinical trials. Applicants proposing to conduct clinical trials should consult with relevant IC staff. Plans for data and safety monitoring must be included in research plans involving Phase I or Phase II clinical trials (see Federal Citations in Section VIII): Generally, this requirement may be satisfied in the submitted application by providing documentation that the sponsoring institution has an approved plan in place and providing a brief description of the key elements of the plan.

6.A.3. Statement of Support

Statement by Mentor, Co-Mentors, Consultants, Contributors (All statements/letters should be appended to each other and uploaded as a single pdf document):

• The candidate must name a primary mentor who, together with the applicant, is responsible for the planning, directing, monitoring, and executing the program. The candidate may also nominate co-mentors as appropriate to the goals of the program.
• The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training and placing independent investigators.
• The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
• Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.
• The application must include a statement from the mentor providing: 1)information on his/her research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; 3) a plan for career progression for the candidate to move from the mentored stage of his/her career to the independent research investigator status during the project period of the award; and 4) a plan for monitoring the candidates research, publications, and progression towards independence.
• Similar information must be provided by any co-mentor. If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any of the co-mentors are not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of personal meetings.
• SPECIAL NOTE: Only very limited use should be made of offsite co-mentors; and the primary mentor should be onsite. The mentor or department chair must agree and provide a statement in the application documenting that the candidate will be provided at least 9 person months (75%) of the full-time professional effort to devote to research and related activities in order to achieve the research objectives of the award.
• Consultant(s)/Collaborator(s): Signed statements must be provided by each consultant/collaborator confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent investigator.
• The mentor must agree to provide annual evaluations of the candidates progress as required in the annual progress report, PHS 2590 (see Section VI.3. Reporting).

6.A.4. Environment and Institutional Commitment to the Candidate

Description of Institutional Environment:

• The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.
• Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.

Institutional Commitment to Candidates Research Career Development:

• The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award.
• Provide assurances that the candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to the development of their research program. The remaining effort should be devoted to activities related to the development of the candidates career as an independent scientist.
• Provide the candidate with appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations) to carry out the proposed research plan.
• Provide appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan.

6.A.5. Letters of Reference

[ January 20, 2011 - Please see NOT-OD-11-036 informing applicants that the Letters of Reference are due by the application receipt deadline date. ]

Electronic submission of reference letters is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons and do not use Grants.gov. Therefore, candidates must follow the Supplemental Instructions in the SF424 R&R Application Guide for Research Career Awards (Instructions, Part 7.3) (see http://grants.nih.gov/grants/funding/424/index.htm).

Letters of reference are an important component of the application for this career award. Applicants for this career award must arrange to have at least three (but no more than five) letters of reference submitted on their behalf to the NIH eRA Commons Web site at https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new. The letters should be from well-established scientists (referees) addressing the qualities of the candidate as well as their potential for becoming an independent investigator. These letters should be from individuals not directly involved in the application, but who are familiar with the candidates qualifications, training, and interests, including advisory committee members (if applicable).

The mentor/co-mentor(s) may also submit letters of reference, but these letters will be considered independently of the three required reference letters. Revised applications must include new letters of reference.

Applications that are missing letters of reference may be considered non-responsive and may not be reviewed.

6.B.2. Environment and Institutional Commitment to the Candidate

Environment and Institutional Commitment:

• Provide a statement of commitment from the sponsoring institution that the course(s) or curricula will become an integral part of the academic offerings of the institution.
• Provide a statement of institutional commitment to provide protected time to the candidate to meet the required effort commitment for this K07 Award. This statement should include a description of 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). These descriptions should be sufficiently detailed so that reviewers can determine if the environment is conducive to the achievement of the objectives of the award.

Collaborator's Statement (s): PD/PIs must include information about any collaborator(s) including her/his research and training qualifications. The application must also include information describing the nature and extent of collaboration that will occur during the proposed award period.

Training in the Responsible Conduct of Research:

• 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 the application lacks this component.
• Applications not providing documentation of prior instruction in the responsible conduct of research 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 PHS 398 Career Development Award Supplemental form Section 7.5.1, and refer to the NIH web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

Budget:

Budget Component (Section 4.7): Use the SF424 (R&R) Detailed Budget component and review the instructions found in Part I.4.7(R&R Budget Component) of the Application Guide. However for K applications only limited budget information is required; therefore, candidates will also need to follow the special instructions in Part I.7.4 of the SF 424 (R&R) [Supplemental Instructions for Career Development Awards], noting the special instructions that modify Section 4.7. In budget section A (Senior/Key Persons) include base salary, person months and requested salary and fringe benefit information for only the candidate. Base salary, and requested salary and fringe benefits should reflect actual levels. Any adjustments based on IC policy limits will be made at the time of the award. Sections B-E should be left blank. If a dollar amount is required, enter 0 (zero) in the appropriate box. The total Research Development Support amount requested for each year will be entered in Section F, Materials and Supplies. In Section H enter Modified Total Direct Costs under Indirect Cost Type. The Indirect Cost rate is 8% of modified total direct cost. The Indirect Cost amount should be entered under Funds Requested. Totals for Sections F, G, and H will be calculated automatically for each year as well as for the Cumulative Budget. Within the direct cost limitation for research development support, provide a detailed description with justification for all equipment, supplies and personnel that will be used to help achieve the career development and research objectives of this award.

6.C. Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the 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 the 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 in which 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 (e.g., 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 (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information

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1. Criteria

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 on the basis of established PHS referral guidelines to the ICs for funding consideration.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate scientific review group(s) in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

As part of the scientific peer review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned an impact/priority score;
• Receive a written critique; and
• Receive a second level of review by the appropriate national advisory council or board.

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

• Scientific merit and quality of the proposed project as determined by peer review.
• Relevance of the proposed career development program, prior training, and commitment of the applicant to becoming an independent research scientist.
• Relevance to the IC program priorities.
• Availability of funds.

Review Criteria

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

• Candidate
• Career Development Plan
• Research Plan
• Mentor, Co-Mentor(s), Consultant(s), and Collaborator(s)
• Environment and Institutional Commitment to the Candidate

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the candidate to maintain a strong research program, in consideration of the following five core review criteria, and additional review criteria. An application does not need to be strong in all categories to have a major impact.

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.

Candidate:

• Does the applicant show a strong commitment to an academic career in cancer prevention, cancer control, epidemiology, or to the behavioral or population sciences as these disciplines relate to cancer prevention and control.
• Does the candidate show the ability to interact and collaborate with other scientists?
• Does the prior scientific training and experience, including publications establish the innovativeness of the candidate's research and a high potential for an independent research career. .
• Does the applicant show potential to become an outstanding investigator, teacher, resource person, and leader in cancer research, educational and (where appropriate) clinical programs?
• Is there likelihood that the award will contribute substantially to the academic and research career development of the candidate?
• Do the letters of reference on behalf of the candidate express the potential and commitment to the planned academic career program in cancer research and the likelihood that the program will meet the candidates career goals to pursue an independent career in cancer research?
• Are sufficient additional relevant information/recommendations submitted by mentor and/or others for review consideration?

Career Development Plan:

• Is the candidates career development plan, including plans for after termination of the award, of high quality and sufficient feasibility?
• Are the content and duration of the proposed didactic and curriculum development components appropriate and reasonable?
• Do the structured activities such as coursework (including course numbers and descriptive titles), seminars or technical workshops, etc., meet the career goals of the candidate?
• Are there appropriate timelines planned for the candidates progress?
• Is there a satisfactory and appropriate relationship of the research plan to the career development goals and the candidates previous experience?

Research Plan:

• Is the research plan appropriate for the candidates past experience and current academic/research goals?
• Is the scientific and technical merit of the research plan appropriate and adequate for developing new or enhancing existing skills needed to meet the candidates career goals?
• Is the plan for coupling the research with other planned activities, appropriate and adequate for providing the experience, knowledge, and skills necessary to achieve the objectives of the award?
• Are the plans to include both genders, children, women, and underrepresented populations and their subgroups as appropriate for the scientific goals of the research adequate? Are the plans for the recruitment and retention of human subjects adequate?

Mentor(s), Consultant(s), Collaborator(s):

• Are the mentors research qualifications including current and pending research support, prior research experience, and mentoring track record appropriate and adequate for guiding the candidate in meeting the goals of the Development Award?
• Do the mentor(s) adequately address the above review criteria including the candidates potential and his/her strengths and areas needing improvement?
• Does the mentors statement demonstrate a strong commitment to the candidates progression to independent academic investigator? For offsite (i.e., not at the same institution as applicants) mentors, are there the appropriate and adequate procedures to ensure an appropriate level of mentoring. Are the combined expertise, roles, and responsibilities of any involved co-mentors, consultants, and/or collaborators likely to enhance the candidates career development?

Environment and Institutional Commitment to the Candidate:

• Is there merit to the institutions plan and commitment to strengthening research and education activities beyond the current status of activities and capacities?
• Is there a strong statement of commitment by the institution to the levels of effort required for this career award?
• Is the scope and nature of collaboration among participating schools and departments appropriate and adequate?
• Are there adequate research facilities and training opportunities for the award?
• Is the quality of the scientific environment and relevance to the candidates professional academic and scientific development, including any unique features of the scientific environment beneficial to the candidate, adequate and appropriate?

2.A. Additional Review Criteria

Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Resubmissions: When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Protections for Human Subjects: For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children: When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. part I, 5.5.

Vertebrate Animals: The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

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

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Training in the Responsible Conduct of Research: Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable. Reviewers will specifically address the five Instructional Components (Format, Subject Matter, and Frequency of instruction as detailed in NOT-OD-10-019. The review of this consideration will be guided by the principles set forth in NOT-OD-10-019. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE.

Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) 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

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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 NIH eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. JIT includes, but is not limited to, updated salary information and confirmation, current Other Support as well as Human Subjects and Animal certifications. Activation of the JIT link in the eRA Commons is not an indication of a request for Just in Time information. The applicant organization will be contacted by NIH grants administration staff if this information is required. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

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

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 Section IV.5 Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

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 request 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 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. Leave Policies: 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 NIH funding component 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.

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

E. Changes in Research or Career Development Program: Consultation with the applicable NIH funding Institute or Center Program staff is strongly encouraged when a change in the approved career development program and/or research plan is being considered.

Individual awards are made for career development in a specific research program. A change in the specified scientific area of the research component of the career development program requires prior approval of the awarding NIH Institute or Center. A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan. The new research plan will be evaluated by staff of the awarding IC to ensure that the plan remains within the scope of the original peer-reviewed research program. If the new plan does not satisfy this requirement, staff could recommend that the award be terminated.

In rare cases where a mentor must be replaced, the institution must submit a letter from the proposed mentor and awardee documenting the need for substitution, the new mentor's qualifications for supervising the program, and the level of support for the PD/PIs continued career development. The letter must also document that the specific aims of the research program will remain within the scope of the original peer reviewed research program. Staff within the NIH funding component will review the request and will notify the institution of the results of the evaluation.

F. Change of Institution or Termination: Consultation with the applicable NIH funding Institute or Center program and/or grants management staff is strongly encouraged when either termination or a change of institution is being considered.

For the K07 Career Development Award, a change of grantee institution 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 PD/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 the K awardee 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 or Center.
• The awardee must establish in the transfer application that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer-reviewed research program, and that a new mentor has been identified who has the appropriate research expertise and support to provide adequate guidance to the awardee and research support for the awardee's research program.
• 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.

When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the Notice of Award (NoA) must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH awarding component 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, the effective date, and the right to appeal the decision.

3. Reporting

Awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement. (Note that the instructions for Research Career Development applications must be followed for this program).

The Progress Report must include Sections (A) through (F) as described in Section 2.2.6 (Progress Report Summary) in the general PHS form 2590 instructions, as well as sections G through J as described in Section 5 of the 2590 instructions. Evaluation of the awardees progress will encompass the following:

• A demonstration of progress toward the aims of the K07 program as described in a brief summary of the studies and results obtained during the prior funding period.
• A description of how this academic career development award has enhanced the candidates proposed academic and research activities including a brief summary of the activities and accomplishments supported by this award during the prior funding period.
• A list of the candidates accomplishments such as publications, scientific presentations, new collaborations, inventions, or project-generated resources made during the prior funding period.
• A description of the proposed activities that will be supported for the next year with a clear indication of the percent effort devoted to all program activities.
• An annual evaluation statement of the candidates progress, as required in the PHS 2590 continuation application instructions (Mentors Report).

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

Section VII. Agency Contacts

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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 (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Susan Perkins, Ph.D.
Program Director
Cancer Training Branch
Center for Cancer Training, NCI
6116 Executive Blvd., Suite 7041, MSC 8346
Bethesda, MD 20892-8346
Telephone: (301) 496-8580
Fax: (301) 480-1744
E-mail: perkinsu@mail.nih.gov

2. Peer Review Contact(s):

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 express/courier delivery)
Telephone: (301) 496-3428
Email: ncirefof@dea.nci.nih.gov

3. Financial/Grants Management Contact(s):

Barbara Liesenfeld
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) 496-3265
Fax: (301) 496-8601
Email: liesenfeld@nih.gov

Section VIII. Other Information

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Required Federal Citations

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

Human Subjects Protection: Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

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

Sharing Research Data: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the impact/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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women, Minorities, and Children: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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

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

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

Human Embryonic Stem Cells (hESC): Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. 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, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicines PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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

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

URLs in NIH Grant Applications or Appendices: All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles.Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs: NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.