Expired PAR-08-033: Promoting Careers In Aging and Health Disparities Research (K01)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

Part I Overview Information

Department of Health and Human Services
National Institutes of Health (NIH), (http://www.nih.gov/)

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations
National Institute on Aging (NIA), (http://www.nia.nih.gov/)

Title: Promoting Careers In Aging and Health Disparities Research (K01)

Announcement Type
New

Program Announcement (PA) Number: PAR-08-033

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

March 27, 2009 - This PA has been reissued as (PAR-09-136).
January 30, 2009 - See Notice (NOT-OD-09-039) This notice announces the expiration of this PAR.

Catalog of Federal Domestic Assistance Number(s)
93.866

Key Dates
Release Date: November 27, 2007
Letters of Intent Receipt Date(s): Not applicable
Application Receipt Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS for guidance on dates
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Additional Information To Be Available (URL Activation Date): Not applicable
Expiration Date: New Date January 30, 2009 (per issuance of NOT-OD-09-039) (Original Expiration Date: January 8, 2011)

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The goals of NIH-supported career development programs are to help ensure that diverse pools of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation's biomedical, behavioral, and clinical research needs.
The focus of this FOA is limited to health disparities related to aging.
For purposes of this funding opportunity, eligible individuals are applicants who have been determined by the grantee institution to be committed to a career in health disparities research related to aging and who are members of or knowledgeable about health disparity population groups. Nationally, health disparity population groups include but are not limited to African Americans, Hispanic Americans, American Indians/Alaska Natives, Native Hawaiians, Pacific Islanders, the medically underserved, low socioeconomic populations and rural populations.
This FOA is related to the NIA Health Disparities Strategic Plan and will help to build capacity in aging and health disparity research. See: http://www.nia.nih.gov/AboutNIA/StrategicPlan/DirectorsMessageHD.htm. The plan is updated annually and makes it clear that health disparity populations are minority populations, low socioeconomic status (SES) population groups, and rural populations groups. Homeless, Medicaid, medically indigent, migrant and disabled population groups may also be included. The goals of the Strategic Plan are to reduce and eliminate health disparities, expand minority health and health disparity research education and training opportunities for underrepresented scientists (individuals from racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds), and to provide information to these groups about treatment, prevention, and management of disease. The most striking disparities in the burden of disease in the United States are experienced by African Americans, Hispanics, American Indians, Alaska Natives, Native Hawaiians and other Pacific Islanders, Asians, disabled individuals, and individuals from low socioeconomic and rural population groups. Scientists from these groups are strongly encouraged to apply as they are well positioned to conduct research aimed at redressing health disparities.
Applications will be supported through the NIH Mentored Research Scientists Development Award Mechanism (K01): http://grants2.nih.gov/grants/guide/pa-files/PA-06-001.html. The K01 application may be submitted on behalf of the candidate (principal investigator) by any domestic for-profit or non-profit institution/organization, or public or private institutions, such as universities, colleges, hospitals and laboratories. Foreign institutions are not eligible to apply.
Candidates must be U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence, who hold a research or health-professional doctoral degree or its equivalent and can commit a minimum of 75% of full-time professional effort conducting research and relevant career development activities specified in the application. Receipt of prior support may affect eligibility.
The candidate must demonstrate and justify the need for a three, four, or five-year period of additional supervised research experience. Planning, direction, and execution of the proposed career development program and research project will be the responsibility of the candidate and his/her mentor.
The proposed career development experience must be on health disparities and aging research and must be sufficiently new to the candidate and/or one in which an additional supervised research experience will substantially augment the candidate’s research capability.
The National Institute on Aging intends to commit up to $500,000 in FY 2008 for awards in response to this FOA. An applicant may request a project period of 3-5 years and a budget for direct costs of up to $150,000 per year.
The total amount to be awarded and the number of anticipated awards will depend upon the quality, duration, and costs of the applications received as determined by peer review process, available funds and program priorities.
The candidate for this K01 award may not concurrently apply for or have an award pending for another NIH career development award. Up to two resubmissions of an application will be accepted. Renewals will not be allowed.
Applications must be submitted on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm.
See Section IV.1 for application and submission information.
Telecommunications for the hearing impaired is available at: TTY 301-451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research 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. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Date and Time
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions

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 Mentored Research Scientist Development Award (K01) provides support for a sustained period of protected time for intensive research career development under the guidance of an experienced mentor, or sponsor, in the biomedical, behavioral or clinical sciences leading to research independence. The expectation is that through this sustained period of research career development and training, awardees will launch independent research careers and become competitive for new research project grant (R01) funding.

The candidate must devote a minimum of 75% of full-time professional effort to the goals of this award. The remainder may be devoted to clinical, teaching, or other research pursuits consistent with the objectives of the award. Both the didactic and research phases of an award period must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the career goals of the candidate.

All career development programs must be tailored to meet the individual needs of the candidate. The candidate and mentor are jointly responsible for the preparation of the plan for the career development program. Applicants must justify the need for this award and provide a convincing case that the proposed period of support will substantially enhance their careers as independent investigators in their chosen area of research. The sponsoring institution must be able to demonstrate a commitment to the development of the candidate as a productive, independent investigator.

In the United States today the most severe health problems are concentrated among minority groups and elders from disadvantaged backgrounds who bear a substantial burden. Research is critically needed to develop basic knowledge, innovative treatments, techniques and programs focused on challenges of reaching racial, ethnic, economic and educationally disadvantaged groups, and on understanding diseases that disproportionately affect the elderly members of these groups and provide appropriate care and treatment.

Disparities in the burden of illness, disease and death experienced by older African Americans, Hispanic Americans, Asian Americans/Pacific Islanders, American Indians/Alaska Natives, and other health disparity population groups as compared to the U.S. population as a whole, can be improved. NIA recognizes that each group is unique and disparities vary within and between groups such that not all experience excess deaths or high prevalence of the same diseases. Additionally, the NIA recognizes the importance of a diverse research workforce committed to research aimed at redressing health disparities where they exist and assisting in the breakdown of racial, cultural and ethnic barriers and stereotypes.

Almost no area of late life health disparity is excluded and inquiry is required to address built environments (place of residence, geographical segregation of medical services, unsafe neighborhoods, safe walking & driving); lifespan experiences (life long disability, societal role in health to include discrimination, end-of-life health expenditures, elder mistreatment, social gradient and inferior quality early life education); culture (traditional foods, resistance to formal medical care, multigenerational caregiving); policy and economics (Has the Medicare drug act made a difference to disparities? Do other recent changes in implementation and direction of federal and state health programs act to increase or decrease disparities in late life?); basic biology, including studies on animal models, of age-related diseases that disproportionately affect racial or minority groups (prostate cancer, cardiovascular disease); as well as aging-related diseases and conditions that disproportionately affect racial and ethnic minority groups (differential diagnosis of Alzheimer s disease, burden of illness, and comparative studies).

Additional research examples may amplify current NIA research in the area of cognitive tests that have poor specificity among ethnic and minority populations and among those with few years of schooling which cannot reliably differentiate subtle impairment associated with the early stages of dementia from the early effects of normal aging since misdiagnosis of dementia is more likely among cognitively normal African Americans as compared to whites. Further, opportunities to reduce disparities fall into several categories, including: broad efforts to reduce socioeconomic inequalities; increasing the number of people with health plan coverage; increasing physical and cultural access to health care; reducing disparities in the quality of care that patients receive; public health strategies to reduce risk factors for chronic diseases and injuries at the community level; and public health strategies to reduce risk that target individuals who may not be in the same community.

Further, research is needed to assist policymakers in decisions about allocation of public health resources consistent with the primary causes of health disparities in the U.S. with emphasis on risk factors for chronic diseases and injuries. Additionally, there are a number of factors that work against a healthy profile for the U.S. Hispanic elderly population. Research is needed to examine existing data sets for relationships among health, mortality and low levels of human capital, access to and use of health care to include uninsured older Hispanics, issues of increased westernization and a diet based on highly processed foods, as well as research to address lingering effects of early child health on burden of disease and disability after age 60.

Although the NIH currently provides many opportunities to develop research careers for individuals that are underrepresented in aging sciences, the National Academies of Science publication Assessment of NIH Minority Research Training Programs: Phase 3, (2005), http://fermat.nap.edu/catalog/11329.html#toc provides strong support that diversity in the science workforce remains a critically important area for advancing the biomedical and behavioral research enterprise and reducing health disparities.

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 K01 award mechanism. As an applicant, the candidate and his/her mentor(s) are jointly responsible for planning, directing, and executing the proposed project and career development 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 budget justification information.

Awards are for three-five years and are not renewable and are not transferable from one principal investigator to another.

2. Funds Available

NIA expects to award up to $500,000 dollars through this announcement.

An applicant may request a project period of up to 3-5 years and a budget for direct costs up to $150,000 dollars per year.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIA 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:

The following costs are allowed within the overall amount described above:

Salary: NIA will provide salary and fringe benefits for the career award recipient. The total salary requested must be based on a full-time, 12-month staff appointment. The award requires the candidate to devote a minimum of 75% of full-time professional effort to conducting the research career development plan described in the application. The remainder may be devoted to clinical, teaching, or other research pursuits consistent with the objectives of the award. For information regarding NIH policy in determining full-time professional effort for career awards, see http://grants.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 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 NIA 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 must not require extra duties or responsibilities that would interfere with the purpose of the K01 award. 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-07-051.html

Effective for all new competing research project grant applications, mentored career award recipients in the last two years of career award support may reduce effort on the career award to a minimum of 50% and hold concurrent support from their career award and a competing NIH research grant if they are recognized as a Principal Investigator or Subproject Director. This policy can be found at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

Research Development Support: Examples of these expenses include: (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; (d) statistical services including personnel and computer time.

Ancillary Personnel Support: Salary for mentors, 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.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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 activities in health disparities research related to aging is invited to work with his/her mentor and sponsoring institution to develop an application for support. Nationally, health disparity population groups include but are not limited to African Americans, Hispanic Americans, American Indians/Alaska Natives, Native Hawaiians, Pacific Islanders, medically underserved, low socioeconomic populations and rural populations. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. However, for this NIH K01 PA the following additional eligibility requirements apply to individuals who seek support as principal investigators:

Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who possesses an Alien Registration Receipt Card (I-151 or I-551), or some other verification of legal admission as a permanent resident 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 research or health-professional doctoral degree or its equivalent. 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., Pharm.D., N.D. (Doctor of Naturopathy), as well as a doctoral degree in nursing research or practice.

Candidates contributing to the diversity of the research workforce on aging and are committed to conduct research on health disparities and aging are encouraged to apply and include:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/sbe/srs/women/start.htm). In addition, it is recognized that underrepresentation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the applicant institution are eligible for support under this program.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who were raised in a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary of Health and Human Services for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or that they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

Candidates must identify a mentor with research experience in aging and sufficient independent research funding to support the proposed research project in excess of the allowable costs of this award .

Candidates must be able to commit a minimum of 75 percent of full-time professional effort conducting research career development and research activities associated with this award. The remaining 25 percent effort can be divided among other research, clinical and teaching activities only if these activities are consistent with the goals of the K01 Award, i.e., the candidate's development into an independent investigator in aging and health disparities 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. Candidates with VA appointments should contact the staff person in the NIA prior to preparing an application to discuss their eligibility, see http://grants.nih.gov/grants/guide/contacts/pa-05-143_contacts.htm.

2. Cost Sharing or Matching

Cost sharing is not required.

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

3. Other-Special Eligibility Criteria

A candidate for an NIH K01 award may not simultaneously submit or have an application pending for any other NIH career award (e.g., K01, K07, K08, K22, K23, K25, K99), a research project grant (R01), or any PHS award that duplicates any of the provisions of the K01 award. Ineligible individuals include current and former principal investigators on NIH research project grants, comparable individual career development awards (e.g., K07, K08, K01, K25) equivalent non-PHS peer-reviewed research grants that are over $100,000 direct costs per year, or project leaders on sub-projects of program project (P01) or center (P50) grants, and the equivalent, such as VA Merit Awards. Recipients of K12 support may apply provided that they have no more than three years of K12 support by the time the K01 award is issued. Former principal investigators of NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) remain eligible.

K01 recipients are encouraged to apply for independent research grant support during the latter period of this award. K01 award recipients that obtain independent support during the K01 award period may hold concurrent research support, and under certain circumstances (see Allowable Costs above) salary support from their career award and a competing NIH research project grant when recognized as a Principal Investigator or subproject Director of the research project grant, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

Special Requirements:

Each career development program must be tailored to meet the individual needs of the candidate. The candidate and mentor are jointly responsible for the preparation of the plan for the career development program in aging and health disparity research. The sponsoring institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator. The candidate must identify a mentor with documented aging-related research experience and sufficient independent research funding to cover the costs of the proposed research project in excess of the allowable costs of this award.

Key elements for the award, in addition to information about the applicant candidate, include:

Environment: The applicant institution must have a well-established record of research career development activities and qualified research faculty to serve as mentor. The institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator and allow the protected time needed by the applicant. The candidate, mentor, and institution must describe a career development program that maximizes the use of relevant research, and educational resources, and qualified faculty as mentors in aging research.

Career Development Program: The award provides three, four, or five consecutive 12-month budget periods. At least 75% of the recipient's full-time professional effort must be devoted to the program although 100% effort may be requested. The remainder of the applicant's time should be devoted to other research-related and/or teaching pursuits consistent with the objectives of the award. The candidate is expected to develop knowledge, skills and expertise relevant to her/his career goals. The candidate may include didactic, laboratory, interdisciplinary and field experiences in their career development plan as needed.

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 research area and have a track record of success in training independent investigators in aging. 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. 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.

Section IV. Application and Submission Information

1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed 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.

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

3. Submission Dates and Times
See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): Not applicable
Application Receipt Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS for guidance on dates
Peer Review Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: 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. However, applicants are encouraged to contact the scientific/research contact at the NIA (listed in Sec. VII) prior to submitting an application, to discuss issues of eligibility and review the specific provisions of the award.

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material should be sent to:

Ramesh Vemuri, Ph.D.
Chief, Scientific Review Branch
National Institute on Aging
7201 Wisconsin Avenue, MSC 9205
Gateway Building, Suite 2C212
Bethesda, MD 20892-9205 (use 20814 for express mail)
Telephone: (301) 496-9666
FAX: (301) 402-0066
E-mail: [email protected]

3. C. Application Processing

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. 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 as described in the Eligibility section of this announcement prior to award (Section III).

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

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. The candidate is required to devote a minimum of 75% of full time effort to this program, and confirmation of the actual salary is required prior to the issuance of an award.

An NIH policy change (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html ) now 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 an NIH research grant or subproject. The K-award recipient must be the named Principal Investigator on a competing NIH 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.).

Research Development Support: The research development support costs allowed for this program must be carefully justified annually and must 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 K01 initial budget period of a new award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing 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

Using the Supplementary Instructions in the PHS 398 for Research Career Awards, the following information must be included in the application.

Candidate:

Describe the candidate's commitment to an academic career in aging and health disparity research. Include a description of all of the candidate's professional responsibilities in the grantee institution and elsewhere and show their relation to the proposed activities on the career award.

Present evidence of the candidate's ability to interact and collaborate with other scientists.

Discuss prior training and how it relates to the objectives and long-term career plans of the candidate.
Discuss the candidate's research efforts to this point in his/her research career, including any publications, prior research interests and experiences in health disparities research.
Provide evidence of the candidate's potential to develop into an independent investigator.
Include a statement that the candidate will commit at least 75% effort to career development activities. The mentor or department chair must agree and provide a statement in the application documenting that this percent of time will be protected.

Career Development Plan:

The candidate and the mentor are jointly responsible for the preparation of the career development plan that reflects interest in aging and health disparities. A timeline is often helpful. The sponsor/mentor may form an advisory committee to assist with the development of the program of study or to monitor the candidate's progress through the career development program.
Describe a systematic plan: (1) that shows a logical progression from prior research and training experiences to the training and research experiences that will occur during the K01 award period and then to independent investigator status; (2) that justifies the need for further career development to become an independent investigator in aging and health disparities; and (3) that utilizes the relevant research and educational resources of the institution.
The didactic and the research aspects of the plan must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the candidate's career goals. The candidate must demonstrate they have received training or will participate in courses such as: basic science, gerontology, life course perspectives, minority health and health disparities, data management, epidemiology, study design, hypothesis development, etc., as well as the legal and ethical issues associated with research on human subjects.
Describe the professional responsibilities/activities including other research projects beyond the minimum required 75% effort commitment to the K01 award. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator conducting aging research related to minority health and health disparities.

Research Plan:

A sound research project that is consistent with the candidate's level of research development and objectives of his/her career development plan must be provided.

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. The candidate should consult with mentor(s) regarding the development of this section. Complementary laboratory research directly related to minority health and health disparity research may be proposed in the application, thereby providing an opportunity for a career development experience in translational 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 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 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, and propose plans to receive 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 Mentor(s)/Consultant(s)/Collaborator(s):

The candidate must name a primary sponsor (or mentor), who, together with the applicant, is responsible for the planning, direction, and execution of 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 aging and have a track record of success in training independent investigators.
The mentor should have sufficient independent research funding to support the proposed research project in excess of the allowable costs of this award.
Where feasible, women, individuals from diverse race and ethnic groups, individuals with disabilities and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research should be involved as mentors to serve as role models.
The application must include a statement from the mentor(s) providing: 1) information on their research qualifications and previous experience as a research supervisor; 2) a mentoring plan describing the nature of the supervision and mentoring that will occur during the proposed award period; 3) a plan for transitioning the candidate from the mentored phase of their careers to the independent investigator phase during the project period of the award; and 4) an assessment of the candidate’s background in health disparities research, level of commitment to a career, and how this individual’s advancement in research will strengthen diversity in aging and health disparities research.
The mentor must agree to provide annual evaluations of the candidate's progress for the duration of the award as required in the annual progress report, PHS 2590 (see Section VI.3 Reporting).
Similar information must be provided by any co-mentor. If more than one 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.

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 that clearly documents expertise in the proposed area(s) of consulting/collaboration.

Environment and Institutional Commitment to the Candidate:

The sponsoring institution must define and document a strong, well-established research and training 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 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 the K01 award.

Describe the resources and facilities that will be available to the candidate.
Describe how the institutional research environment of the institution is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.
In a clear statement, provide assurances that the candidate will be able to devote a minimum of 75% of his/her effort developing his/her research program, that the remaining percent effort will be devoted to activities related to the development of his/her research career, and that the candidate will be released from normal clinical, teaching or administrative duties. Candidates who will use the resources within a General Clinical Research Center (GCRC) during the course of their award should include a letter of agreement from either the GCRC program director or the principal investigator as part of the application.

Letters of Reference:

Include with the application three sealed letters of reference from well-established scientists addressing the above areas and any other evidence that the candidate has a high potential for becoming an independent investigator in aging and health disparities research. The mentor(s) may also submit letters of reference, but these letters will be considered independently of the three recommendations. All sealed letters of reference should be attached to the face page of the application.

Budget for the Entire Proposed Period of Support:

Follow the application instructions, providing only the total direct costs for each year and the entire proposed period of support. 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 data is not required.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (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 and any related data sharing plans 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).

Not applicable

2. Review and Selection Process

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

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 National Advisory Council on Aging.

The following will be considered in making funding decisions:

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

Review Criteria

The goals of NIH-supported career development programs are to help ensure that diverse pools of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation's biomedical, behavioral, and clinical research needs. A major goal of this FOA is to support research career development in aging and health disparities research. The scientific review group will address and consider each of the following criteria in assigning the application's overall score, weighting them as appropriate for each application.

Candidate
Career Development Plan
Research Plan
Training in the Responsible Conduct of Research
Appropriateness of and statements by Mentor, Co-Mentor(s), Consultant(s), and Collaborator(s)
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

Potential to develop as an independent and productive researcher
Quality of the candidate's research, academic and (if relevant) clinical record;
Commitment to meeting the program objectives to become an independent researcher;
Quality of the letters of reference from three well-established scientists evaluating the candidate's potential to pursue an independent health-related research scientist career;
Letters of reference submitted by mentor(s)/ co-mentor(s) will be considered independent of and in addition to of the three required reference letters.

Career Development Plan

Likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence, based on:

Appropriateness of the content, scope, phasing, and duration of the career development plan when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence;
Plans for monitoring and evaluating the candidate's research and career development progress.

Research Plan

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

Scientific and technical merit of the research question, design and methodology;
Relevance of the proposed research to the candidate's career objectives;
Appropriateness of the research plan to the stage of research development and as a vehicle for developing the research skills described in the career development plan.

Training in the Responsible Conduct of Research

Quality and appropriateness of the proposed training in the responsible conduct of research.

Statements by Mentor/Co-Mentor(s), Consultant(s), and Collaborator(s)

Appropriateness of the mentor's research qualifications in the area of the proposed research;
Quality and extent of the mentor's proposed role in providing guidance and advice to the candidate;
Previous experience in fostering the development of independent investigators;
History of research productivity and peer-reviewed support;
Adequacy of active/pending support for the proposed research project; and
Strength of the mentor's statement

Environment and Institutional Commitment

Clear commitment of the institution to ensure that a minimum of 75% of the candidate's effort will be devoted directly to research, with the remaining percent effort being devoted to activities related to the successful development of a research career including clinical responsibilities.
Strength of the institutional commitment to the career development of the candidate.
Adequacy of research facilities and training opportunities, including faculty capable of productive collaboration with the candidate.
Quality and relevance of the environment for the scientific and professional development of the candidate.
Assurance that the institution intends for the candidate to be an integral part of its research program.

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

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

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

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research career development plan.

2.C. Sharing Research Data

Not Applicable

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement 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 plans with the awardee before recommending funding of an application. The final version of the resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). 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 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. 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 that 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 funding 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 K01 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 percent. 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 percent 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 percent 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

See http://grants.nih.gov/grants/guide/contacts/pa-05-143_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, program staff could recommend that the award be terminated.

E. Change of Institution or Termination

Consultation with the applicable NIH program staff is strongly encouraged when either a change of institution or termination is being considered, see http://grants.nih.gov/grants/guide/contacts/pa-05-143_contacts.htm.

A change of 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, and the qualifications of the proposed new mentor. 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 Principal Investigator 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.
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 period.

When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the 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 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 (http://grants.nih.gov/grants/funding/2590/2590.htm) 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, 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 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 description of career development and research-related activities undertaken 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 training and other activities.
An annual evaluation statement of the candidate's progress by the mentor(s), as required in the PHS 2590 continuation application instructions (item j. Sponsor's 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:

Dr. J Taylor Harden
Office of Special Populations
National Institute on Aging
31 Center Drive,
Bethesda, MD 20892-2292
Telephone: (301) 496-0765
FAX: 301-496-2525
Email: [email protected]

2. Peer Review Contacts:

3. Financial or Grants Management Contacts:

Linda Whipp, Chief
Grants and Contracts Management Office
National Institute on Aging, NIH
7201 Wisconsin Avenue
Suite 2N212
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
Fax: (301) 402-3672
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

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

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

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

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

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

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

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

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. 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.

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

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

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

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