Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Career Objectives

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

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

Section IV. Application and Submission and Instructions
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Career Objectives

The Independent Scientist Award (K02) is intended to foster the development of outstanding scientists and enable them to expand their potential to make significant contributions to their field of research. It provides three, four, or five years of salary support and protected time for newly independent scientists (see IC provisions) who can demonstrate the need for a period of intensive research focus as a means of enhancing their research careers. Each independent scientist career award program must be tailored to meet the individual needs of the candidate. The sponsoring institution must demonstrate a commitment to provide the environment, resources and the protected time required for the candidate to perform the activities included in the proposed research and career development plans.

The participating NIH Institutes and Centers (ICs) have distinctive guidelines, requirements, salary and research support levels provided under the auspices of this funding opportunity announcement in order to accommodate the career needs of researchers working in fields related to their specific research missions. Potential applicants are strongly advised to contact the appropriate NIH staff member identified in Section VII (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-527_contacts.htm) to discuss their particular circumstances and eligibility for the K02 award before developing an application.

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

Section II. Award Information

1.Mechanism(s) of Support

This funding opportunity will use the NIH K02 award mechanism. The candidate and sponsoring institution will be responsible for planning, directing, and executing the proposed project and independent scientist award activities.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). The applicant should follow the instructions for budget information described in the PHS 398, Section III, providing only the total direct costs for each year and the entire proposed period of support and a budget justification.

Project periods may be for up to five years, at least three years are required. Awards may be competitively renewed at the discretion of the participating NIH Institutes and Centers. Only a few of the NIH awarding components permit competitive renewals of this award; see http://grants.nih.gov/archive/grants/guide/contacts/pa-06-527_contacts.htm.

2. Funds Available

The number of awards and the total amount of funding expected to be awarded by the participating ICs will vary and depend on the number and quality of the applications received and availability of funds, and program priorities.

Because the nature and scope of the proposed independent career 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.

Allowable Costs:

Salary: The participating NIH Institute or Center will provide salary and fringe benefits for the independent scientist career award recipient. The total salary requested must be based on a full-time, 12 month staff appointment. The candidate will be required to devote a minimum of 75% (or 9.0 calendar months) of full-time professional effort to conducting research with the remaining effort being devoted to activities related to the further development of a successful independent research career consistent with the objectives of the award. For information regarding NIH policy in determining full-time professional effort for career awards see http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html

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 institution’s 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 K02. Under expanded authorities, however, institutions may rebudget 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/guide/notice-files/NOT-OD-05-023.html.

Research Development Support: It is expected that most candidates for a K02 award will have research support at the time of the award. There are some research specialties, however, in which only minimal research support is needed, i.e., theoreticians, statisticians, and computer scientists. In such cases, incidental research expenses may be requested at the time of application and provided at the discretion of the participating NIH Institute and Center. See http://grants.nih.gov/archive/grants/guide/contacts/pa-06-527_contacts.htm.

When provided, these funds 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 and computational services including personnel and computer time. In no case may funds be requested that duplicate funds already being provided by other research support.

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

Facilities and Administrative Costs: These costs, which were formerly called indirect costs, will be reimbursed at eight percent of modified total direct costs.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

• For-profit organizations
• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Domestic Institutions

Foreign institutions are not eligible to apply.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research and career development plans is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are always encouraged to apply for NIH programs. However, for the NIH K02 program, the following eligibility requirements apply to individuals who seek to become Independent Scientist Award recipients (Principal Investigators).

Only U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who possess an Alien Registration Receipt Card (I-151 or 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.

Candidates for this award must have a doctoral degree and independent, peer-reviewed support at the time the award is made. Some of the participating NIH ICs require the candidate to have an NIH research grant at the time of application and that the support be from their IC. Other NIH ICs will accept candidates with peer-reviewed, independent research support from other sources. See http://grants.nih.gov/archive/grants/guide/contacts/pa-06-527_contacts.htm.

Candidates must be able to commit a minimum of 75 % (or 9.0 calendar months) of full-time professional effort conducting research and research career development related activities during the period of this award. In addition, the candidate must be able to demonstrate that the requested period of salary support and protected time will foster his/her career as a highly productive scientist in the indicated field of research. The candidate 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 toward satisfying the full time requirement at the applicant institution.

2. Cost Sharing or Matching

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

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

3. Other-Special Eligibility Criteria

SPECIAL REQUIREMENTS

The applicant institution must have a well-established record of research career development activities and demonstrate a commitment to research and to the continuing development of the candidate as a productive independent scientist. The institution must provide assurance that the candidate is an integral part of its research and academic program and must certify that the candidate will be released from other duties and be able to devote at least 75% effort to the research program. The institution must also delineate the duties from which the candidate will be released in order to devote this effort.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact Grants Info, Telephone (301) 710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

Applications must be prepared using the PHS 398 research grant application instructions and forms. Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See also Subsection VI.2. for additional information.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

SUPPLEMENTARY INSTRUCTIONS for Career Development awards are located in the PHS 398, Section III.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates

Letters of Intent Submission Date(s): Not applicable.
Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS for guidance on dates.
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent

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

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions
and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

3.C. Application Processing

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

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

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

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

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (See also Section VI.3. Reporting).

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

Concurrent Awards: A candidate for an NIH K02 Award may not simultaneously submit or have an application pending for any other PHS career award (e.g., K24, K05). Applicants may submit research project grant (RPG) applications at the same time as the K02 application. However, any concurrent RPG application may not duplicate the provisions of the K02 application.

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. Confirmation of the actual salary is required prior to the issuance of an award. The candidate is required to devote a minimum of 75% (or 9.0 calendar months) of full time effort to this program. Prospective applicants should contact the applicable NIH component to ascertain amounts associated with this program.

Research Development Support: Any research development support costs allowed for this program must be carefully justified annually and must not duplicate funds provided in other funded research support programs. (Refer to Section II, 2. Funds Available, and the http://grants.nih.gov/archive/grants/guide/contacts/pa-06-527_contacts.htm.

Data and Safety Monitoring: Individual NIH institutes may have specific requirements for data and safety monitoring of clinical trials. Applicants proposing to conduct clinical trials should refer to the http://grants.nih.gov/archive/grants/guide/contacts/pa-06-527_contacts.htm.

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 competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation 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 http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Follow the Supplementary Instructions in the PHS 398 for Research Career Awards (Instructions, Part III) and include the following information in the application.

CANDIDATE

Describe the candidate’s commitment to a career in biomedical, behavioral or clinical research. Include a description of all of the candidate’s professional responsibilities in the grantee institution and elsewhere and show their relationship to the proposed activities of this K02 award.

• Present evidence of the candidate's ability to interact and collaborate with other scientists.
• Present evidence of the candidate’s success as an independent investigator and his/her potential to make future contributions to the chosen field of research.
• Describe the candidate’s immediate and long-term career objectives. Explain how the K02 award will contribute to these goals, and further the candidate’s research career and ultimate impact on science.
• Describe how this award will relieve the candidate of current duties so that a greater portion of the candidate’s effort (at least 75%) may be devoted to research and related career development activities.

CAREER DEVELOPMENT PLAN

• Describe a career development plan, incorporating consideration of the candidate’s goals, prior experience, and current research support. Candidates are encouraged to provide a timeline for accomplishing these goals.

RESEARCH PLAN

• Organize the research plan as indicated in the Form PHS 398, following instructions for the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, and Research Design and Methods.
• Describe plans for the recruitment and retention of subjects and plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research.
• Studies that involve clinical trials (biomedical and behavioral intervention studies) must include a description of the plan for data and safety monitoring of the research and adverse event reporting to ensure the safety of subjects (see Federal Citations in Section VIII).

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH

• Applications must include a description of a program to provide 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 on page 49 of the PHS-398 application package and refer to the NIH web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance. Document prior instruction in or propose plans for instruction in the responsible conduct of research in terms of subject matter and duration of instruction. An award cannot be made if an application lacks this component.

STATEMENT(S) BY CONSULTANT(S)/COLLABORATOR(S)

• When applicable, the application should include signed statements from each consultant/collaborator confirming their participation in the project and describing their specific roles. Information should be provided clearly documenting their expertise in the proposed areas of consulting/collaboration. Any other opportunities for the candidate’s professional growth should also be documented in these statements.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT TO THE CANDIDATE

The sponsoring institution must define and document a strong, well-established research program related to the candidate's area of interest including a high-quality research environment with staff capable of productive collaboration with the candidate. The sponsoring institution must provide a statement of commitment to the candidate's goals for career development into a productive, independent scientist 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 the K02 award.

• Describe the facilities, supplies, equipment, and human resources that will be available to the candidate.
• Describe how the research environment of the institution is particularly suited to enhance the development of the candidate's research career as an independent scientist and proposed career development and research plans.
• In a clear statement, provide assurances that the candidate will be released from other duties and be able to devote a minimum of 75% (or 9.0 calendar months) of his/her effort in the development of his/her research program, with the remaining percent effort being devoted to activities related to the development of his/her career as a research scientist.
• Provide assurance that the candidate is an integral part of the institution’s research and academic program.

BUDGET FOR ENTIRE PROPOSED PERIOD OF SUPPORT

Allowable costs for the NIH K02 program are not uniform throughout the participating Institutes; therefore the salary amounts as well as the research development costs vary, see http://grants.nih.gov/archive/grants/guide/contacts/pa-06-527_contacts.htm.

Follow the application instructions, providing only the total direct costs for each year and the entire proposed period of support. Within the direct costs 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.

Plan for Sharing Research Data

A plan for sharing research data is not required.

Sharing Research Resources

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

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

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

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

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to a Scientific Review Group on the basis of established PHS referral guidelines.

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

As part of the initial merit review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Will receive a written critique
• Will receive a second level of review by the appropriate national advisory council or board.

Applications will compete for available funds with all other approved career development award applications. The following will be considered in making funding decisions:

• Scientific merit and quality of proposed applications as determined by peer review
• Appropriateness of the proposed career development program, prior training, and commitment of the applicant to a career as an independent scientist
• Relevance to program priorities
• Availability of funds

REVIEW CRITERIA

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

The application does not need to be strong in all categories to receive a high priority score. These criteria are listed in logical order and not in order of priority.

CANDIDATE

• Capacity to carry out independent research;
• Potential to become an outstanding scientist who will make significant contributions to the field;
• Past and present research productivity as evidenced by contributions to the scientific literature, and success in obtaining independent funding;
• Ability to conceptualize and organize a long-term research approach;
• Evidence of current independent, peer-reviewed research support; and
• Level of training, experience, and competence commensurate with the purposes of the award.

CAREER DEVELOPMENT PLAN

RESEARCH PLAN

Many Institutes and Centers require the candidate to have an independent, peer reviewed research support at the time the K02 award is made (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-527_contacts.htm). In such instances, reviewers should not re-evaluate the research plan. Rather, the reviewers should evaluate how the research and career development plans together further the candidate’s research career.

• Quality of research plan and potential for advancing the field of study;
• Scientific and technical merit of the proposed research plan;
• When applicable for the specific candidate and situation, letters from consultant(s) and collaborator(s) documenting their willingness to participate in the independent scientist award program and describing their roles; and
• Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT

• Commitment of the institution to the development of the candidate as an independent scientist and assurances that the candidate will be an integral part of its research and academic program;
• Commitment of the institution to ensure that the candidate’s full time effort (at least 75 %) will be set aside to pursue research and career development activities;
• Strength of the institution’s commitment to scientific research; and
• Adequacy of research facilities and resources.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Training in the Responsible Conduct of Research: Quality and appropriateness of the proposed training or instruction in areas related to the responsible conduct of research.

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research career development goals, research aims, and plans.

2.C. Sharing Research Data

A data sharing plan is not required.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the resource sharing plan with the principal investigator before recommending funding of an application. The final version of the resource sharing plan negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award Notices

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

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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

A. Evaluation

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

B. Other Income

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

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

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

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

C. Special Leave

Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the NIH awarding institute or center is required. Details on the process for submission of prior approval requests can be found in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/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 K02 award will continue during such leave.

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

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

Under unusual and pressing 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 other sources of funding, job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. 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.

D. Changes in Research or Career Development Program

Consultation with the applicable NIH program staff is strongly encouraged when a change in the approved career development program and/or research plan is being considered; see http://grants.nih.gov/archive/grants/guide/contacts/pa-06-527_contacts.htm.

Individual awards are made for career development at a specific institution 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. 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 NIH component institute 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.

E. Change of Institution or Termination

Consultation with the applicable NIH program staff and/or grants management staff is strongly encouraged when either a change of institution or termination is being considered.

A change of grantee request normally will be permitted only when all of the benefits attributable to the original grant can be transferred, including equipment purchased in whole or in part with grant funds. In reviewing a request to transfer a grant, NIH will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project. A change may be made without peer review, provided the PI plans no significant change in research and career development objectives and the facilities and resources at the new organization will allow for successful performance of the project. If these conditions or other programmatic or administrative requirements are not met, the NIH awarding office may require peer review or may disapprove the request and, if appropriate, terminate the award.

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

• A relinquishment 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.
• 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.
• All conditions of the award are met at the new institution.
• The period of support requested is not more than the time remaining within the existing award period.

When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the Notice of Award 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 therefore, the effective date, and the right to appeal the decision.

3. Reporting

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

The Progress Report must include Sections a through f as described on pages 10-14 in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV of the 2590 instructions. Evaluation of the awardee’s progress will encompass the following:

• A demonstration of scientific progress toward the aims of the research as described in a brief summary of the studies and results obtained during the prior funding period;
• A list of accomplishments such as publications, scientific presentation, new collaborations, inventions, or project-generated resources made during the prior funding period;
• A brief explanation of plans to address the specific aims during the next year of support;
• A description of proposed career development and research-related activities for the next year of support with a clear indication of percent effort devoted to research, research career development and other activities.
• An annual evaluation statement of the candidate’s progress, as required in the PHS 2590 continuation application instructions (item J. Sponsor’s Report). For the K02, which is an award without a sponsor/mentor, the person responsible for the candidate’s research career development should sign the 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

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

1. Scientific/Research Contacts:
Applicants should refer to the NIH Web site (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-527_contacts.htm) for information regarding each IC’s scientific/research contacts for this K02 program.

2. Peer Review Contacts:
Not applicable

3. Financial or Grants Management Contacts:
Applicants should refer to the NIH Web site (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-527_contacts.htm) for information regarding each IC’s grants management contact for this K02 program.

Section VIII. Other Information

Required Federal Citations

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

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

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity, and dose-finding studies (phase I); efficacy studies (Phase II) efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 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, local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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

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

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

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

Human Embryonic Stem Cells (hESC):

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

NIH Public Access Policy:

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

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

Additional information regarding the NIH Public Access Policy can be found at: http://publicaccess.nih.gov/index.htm

Additional information regarding the submission process can be found in the Public Access Policy Author’s Manual found at: http://publicaccess.nih.gov/publicaccess_Manual.htm.

Access to Research Data through the Freedom of Information Act:

The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Standards for Privacy of Individually Identifiable Health Information:

The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply).

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 Grants 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) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Health People 2010:

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

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance No. 93.398 at http://www.cfda.gov/, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.

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:

Please note that 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 Loan Repayment Program (LRP) is an important component of NIH’s efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, because 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 research. For further information, please see: www.lrp.nih.gov

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