Expired RFA-AG-08-006: Paul B. Beeson Career Development Awards in Aging (K08 & K23)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
National Institute on Aging, (NIA), (http://www.nia.nih.gov/)
Office of Dietary Supplements (ODS), ( http://dietary-supplements.info.nih.gov/)

Title: Paul B. Beeson Career Development Awards in Aging (K08 & K23)

Announcement Type
This is a modification and re-issuance of RFA-AG-07-001, which was previously issued October 02, 2006.

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

July 9, 2008 - This RFA has been reissued as (RFA-AG-09-012).

Request For Applications (RFA) Number: RFA-AG-08-006

Catalog of Federal Domestic Assistance Number(s)
93.866

Key Dates
Release Date: September 28, 2007
Letters of Intent Receipt Date: November 18, 2007
Application Receipt Date: December 18, 2007
Peer Review Date: March 2008
Council Review Date: May 2008
Earliest Anticipated Start Date: July 1, 2008
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: December 19, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

This program provides three to five years of mentored career development support to clinically-trained faculty members in strong research environments to enable them to gain skills and experience in aging research, under the guidance of a mentor or mentors, and to establish an independent program of research in this field. It also includes an annual meeting that allows opportunities to partner with national mentors and fellow awardees.

The FY 2008 anticipated amount is $1.8 million.
The anticipated number of awards is 8 to 12.
The mechanisms are the NIH K08 (Mentored Clinical Scientist Development Award) and K23 (Mentored Patient-Oriented Research career Development Award).
Eligible organizations include: For-profit or non-profit organizations; Public or private institutions, such as universities, colleges, hospitals and laboratories; Foreign institutions are not eligible to apply.
Eligible principal investigators include individuals with a clinical doctoral degree who are U.S. citizens or permanent residents of the U.S. by the time of award, and who have not received R01 or similar support as a principal investigator. Applicants for the K23 mechanism also should have completed clinical specialty training by the time of award.
Renewals and Resubmissions: Resubmissions are allowed as responses to this FOA. See Section IV. 3. C for information particular to resubmissions. Generally competing renewal awards are not allowed. See Section II. 2. where a specific exception is described.
Applicants may submit only one application in response to this RFA.
See Section IV.1 for application materials.
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(s) of Support
2. Funds Available

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

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

The National Institute on Aging (NIA), and the NIH Office of Dietary Supplements (ODS), working in part with funds contributed by the John A. Hartford Foundation (http://www.jhartfound.org/, The Atlantic Philanthropies (http://www.atlanticphilanthropies.org/, the Starr Foundation (http://www.starrfoundation.org/) and The American Federation for Aging Research (http://afar.org/), are pursuing this initiative to sustain and promote the research careers of clinically trained individuals who are pursuing research careers in aging.

The program is named after Dr. Paul B. Beeson who profoundly influenced the career paths of many physicians, including several who now form the core leadership in geriatric medicine. Dr. Beeson was Chairman of Medicine at Emory and Yale Medical Schools, Nuffield Professor at Oxford University and Professor and distinguished VA Physician at the University of Washington. He chaired the first Institute of Medicine study on "Aging and Medical Education" in 1978. His leadership as an editor of the Cecil Textbook of Medicine greatly influenced medical education. From his research and patient care base, he grew increasingly interested in the process of aging, and this interest led to a commitment that included his editorship of the Journal of the American Geriatrics Society. Dr. Beeson died in August 2006 at the age of 97.

The aims of the Paul B. Beeson Career Development Awards in Aging (BCDA) program are:

To encourage and assist the development of future leaders in the field of aging by supporting clinically-trained (primarily physician) faculty members early in their careers to gain additional research training and to establish independent programs in aging research.

To deepen the commitment of research institutions to academic research in aging and to translating research outcomes to geriatric medicine by involving mentor and recipient in establishing and advancing the recipient's career in aging research.

To expand clinically-relevant research on aging broadly defined to include work in the basic sciences, including animal models of aging where there is apparent clinical relevance; maintenance of health and independence in old age; diseases and disabilities of old age; and issues in the clinical management, and systems of care for the elderly.

The BDCA program now includes additional support for clinically trained scientists who wish to pursue careers dedicated to research on Alzheimer’s disease and other neurodegenerative diseases, formerly supported by the Alzheimer’s Disease Clinical Scientist Development Award announcement. Up to three additional awards each year will be dedicated to investigators planning careers in neuroscience related to aging and neurodegenerative disease.

Overall the program will foster the independent research careers of clinically trained investigators whose research will enhance the health and quality of life of Americans, particularly older people.

Research Objectives

The numbers of physicians and other clinically-trained individuals who are committing to and sustaining independent research careers in the biomedical sciences remain inadequate to address the opportunities for translational research, interdisciplinary collaboration, and groundbreaking basic research being generated by advances in genetics, biomedical engineering, and other life sciences. Within the field of aging research the small numbers of individuals receiving training in geriatrics, and the smaller numbers pursuing research on aging remain inadequate to address the burgeoning needs of the rapidly growing older population. The aging of the American population requires a substantial investment in current and future faculty who will devote their careers to advancing knowledge of effective prevention and management of illness and disabilities, and to inspire successive generations to do the same.

This program provides support to clinically-trained faculty members in strong research environments to enable them to gain skills and experience in clinically-relevant aging research and to establish an independent program of research in this field. If you are such a faculty member and wish to apply for this program you must identify a mentor or mentors. These individuals should be senior researchers in aging and/or geriatrics who agree to commit time to supervising and guiding you during the period of the award.

Program:

The BCDA is intended to provide you with the resources and time to establish yourself as an independent and funded investigator whose research focuses on clinically-relevant topics in aging. It is targeted primarily at individuals who have had some prior training in research coursework, methods, and resources related to aging research and who have received initial funding for research such as through Small Grant (R03) support from NIH, through similar support from other federal agencies, or through foundation funding. As a career development award it will allow you time to expand your research training and skills to permit your emergence as a leader in aging research. As such your career development plan should reflect a detailed strategy to advance your research skills that complements the research that you will be undertaking.

Junior candidates (who have not yet received initial research support) may apply where you have shown clear evidence of early leadership potential through academic honors and awards and early research accomplishment. The career development plan should be tailored to your particular career goals, your current level of experience and the environment (including mentors) in which your career development will take place. Junior candidates with limited prior research training and research experience or more senior candidates who are changing or expanding research areas will more likely need longer periods of support on the BCDA, didactic coursework, and guided research experiences than those with more research training and experience in their proposed field of study. More senior candidates who are now expanding their research efforts within their chosen field of study and transitioning to full independence should clearly state their specific career goals and how these goals will be realized through the proposed program of career development under this award. It is particularly important to show those career development activities that are essential to advance to independence, that complement the research planned, and that could not be accomplished through research support alone. Similarly it is important to show that the mentoring available through this award will clearly benefit your emergence as a leading researcher in your chosen field.

To accommodate these differences in prior experience or intended direction the initial BCDA award may be from three to five years. In addition, clinically-trained candidates with limited research experience are eligible for an up to two year competing continuation of the BCDA as described under Funds Available (Section II.2). Candidates who have a research doctorate earned prior to receiving the BCDA are not eligible for this competing continuation. Your program must be tailored to your individual needs and ensure that you will gain the experience, knowledge and skills necessary to carry out high quality clinically-relevant aging research. You and your mentor(s) are jointly responsible for the preparation of the plan for this program.

You must devote at least 75% (nine person-months) of your full-time professional effort to the goals of this award. You may devote the remainder to activities that are consistent with the purpose of the award and which allow you to develop the necessary experience, knowledge and skills to become an independent researcher in a clinically-relevant field of aging. The BCDA program allows support for your salary, and for research/research development expenses to be used for research and training.

The proposed training and research must focus on clinically-relevant research on aging and/or the aged. Your research project may be in the basic sciences, use animal models, or employ primary or secondary data analysis as well as clinical and patient-focused methods. The full range of research methods appropriate to completing the proposed investigation is encouraged provided that the application makes clear the clinical-relevance of the proposed work. ODS has particular interests in the roles of dietary supplements in preventing and reducing risk factors for disease and in enhancing physical and mental health and performance. ODS is also interested in research exploring the biochemical and physiological effects of supplements and in improved scientific methods for the study of dietary supplements. Research on these interests as they relate to the health and performance of older adults is particularly encouraged. The BCDA program also now includes funding for up to three additional positions formerly allocated to the NIA Alzheimer’s Disease Clinical Scientist Development Award program and therefore encourages additional applications addressing innovative approaches to neuroscience research that would have relevance to brain aging, Alzheimer’s disease and other neurodegenerative diseases.

Mentor(s): You must name a primary mentor, who together with you is responsible for the planning, direction, and execution of the program. Your mentor should be an accomplished investigator in the proposed research area and have a track record of success in training independent investigators. You may also nominate co-mentors as appropriate to the goals of the program. It is important that research expertise in the fields of aging and an appropriate funding history of support for aging research be well-represented among your mentors. Where feasible, women, minority individuals and individuals with disabilities should be involved as mentors to serve as role models.

In addition your institution must have a well-established research and clinical career development program with an emphasis or specialty in geriatrics and/or other areas of aging-related research. It must have faculty qualified in aging research to serve as mentors. Your institution must demonstrate a commitment to your development as a productive, independent investigator in aging-related research. Such commitment may be expressed in terms of the expected distribution of resources to you (for example, an independent laboratory) as you progress through the BCDA.

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

Section II. Award Information

1. Mechanisms of Support

This funding opportunity will use the NIH Patient-Oriented Research Career Development (K23) award mechanism (for applications pursuing patient-oriented research); and the NIH Mentored Clinical Scientist Development (K08) award mechanism (for applications that do not involve direct interaction with human participants).

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

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). Follow the budget instructions described in the PHS 398 form section on research career development awards.

2. Funds Available

The National Institute on Aging, and ODS, intend to commit (in combination) approximately $1.8 million in FY 2008;

8 to 12 awards are anticipated;
awards will be made for three, four or five years. (Note considerations in Section II, 1. Research Objectives above);
applicants may seek up to $200,000 (direct costs) per year. Direct costs requested across all years may be no more than $600,000 for three year awards; $700,000 for four year awards; and $800,000 for five year awards. Awarded amounts may be significantly lower than these amounts (see below);
the anticipated start date is July 1, 2008.

The John A. Hartford Foundation, The Atlantic Philanthropies, The Starr Foundation and the American Federation for Aging Research have agreed to contribute to this initiative by providing supplemental awards to increase the number of candidates funded and/or by making independent awards and by sponsoring an annual meeting of the funded investigators and primary mentors. NIA strongly encourages you to share your application with these foundations and to share the results of peer review with them. You may send your application to the American Federation for Aging Research (AFAR) at the address below. AFAR will share it with the other listed foundations:

American Federation for Aging Research
Attn: Paul B. Beeson Career Development Awards in Aging Program
55 West 39th Street, 16th Floor
New York, NY 10018

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, and ODS 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.

Some awardees may be eligible for a competing continuation of the Beeson award. Clinically-trained applicants with no prior NIH career development or similar award from other sources prior to the initial BCDA may seek support for one competing continuation of the BCDA. This continuation may not request support for more than two additional years. The two year direct costs are limited to $300,000 with no more than $200,000 allowed in any one year. However, if you possess a research doctorate you are not eligible for the two-year continuation.

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

1. Salary: The NIA, and ODS, will provide salary and fringe benefits for you. The total salary requested must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at your 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. The salary awarded may be no more than the legislative cap in effect at the time of award. Information on the current legislative limit is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-024.html.

At least 75% (nine person-months) of full-time effort must be devoted to the goals of this award. Because the salary amount provided by this award is based on your full-time institutional salary, other PHS funds may not be used to supplement the salary. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the BCDA. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale provided that the resulting salary is within the current legislative cap.

If you obtain independent research funding as principal investigator of an NIH research grant award in the final two years of the BCDA, at the time the new research grant is awarded, the effort required on the career award may be reduced to no less than 50 percent (six person-months) and replaced by effort from the research award so that the total level of research commitment remains at 75 percent or more for the duration of the mentored career award. See: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html for further details about this policy.

2. 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.

3. Ancillary Personnel Support: Salary for secretaries and administrative assistants is not allowed. Support for mentors is not allowed.

4. Facilities and Administrative Costs: NIA and ODS will reimburse these costs at 8 percent of modified total direct costs. The participating foundations do not pay facilities and administrative 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 or non-profit organizations
Public or private institutions, such as universities, colleges, hospitals, and laboratories
Domestic institutions

Foreign organizations are not eligible to apply .

1.B. Eligible Individuals

If you have the skills, knowledge, and resources necessary to carry out the proposed research then you are invited to work with your institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. However, for the BCDA program, the following additional eligibility requirements apply to individuals who seek to become BCDA recipients (Principal Investigators).

You must have a clinical doctoral degree (e.g., MD, DO, DDS) or its equivalent. Note that individuals with a doctoral degree that require a dissertation or thesis may apply for the BCDA program. These may include individuals holding both MD and PhD degrees as well as individuals with PhDs in clinical fields (such as clinical psychology, nursing, or physical therapy). However, such individuals are not eligible for a competing continuation of the BCDA.

For the K23 mechanism, in addition, you must have completed your clinical training, including specialty and, if applicable, subspecialty training prior to receiving an award. However, you may submit an application prior to completing clinical training. For either the K23 or K08 mechanism you must identify a mentor with extensive research experience, and you must be willing to spend a minimum of 75 percent (nine person-months) of full-time professional effort conducting research career development and research on aging.

At the time of award, you 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. In addition, you must be a citizen or noncitizen national of the United States, or have been lawfully admitted to the United States for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or other legal verification of such status). Noncitizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. If you have questions concerning your eligibility you may seek advice from the Agency Contacts listed in Section VII.

Ineligible individuals include current and former principal investigators on NIH research project (R01), FIRST Awards (R29), sub- projects of program project (P01) or center grants (P50). Former mentored career awardees (K01, K08, K22, K23, K25) are also not eligible for these awards. Some current mentored career award holders are eligible for these awards. See Section III.3. Other Special Eligibility Criteria for further details. Principal investigators of NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) remain eligible.

We strongly encourage you to apply for independent research grant support (such as an R01 or similar award) during the period of this award to maximize your chances of obtaining uninterrupted funding as you transition to full independence.

2. Cost Sharing or Matching

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

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

You cannot hold the BCDA concurrently with another NIH career development award or similar award. You must terminate that other award in order to receive the BCDA. Normally support from the prior career development award and support from the BCDA should add to no more than five years. Requests for time beyond five years of total career award support (including requests for competing renewals of BCDAs) must be justified by indicating changes in circumstances, such as a change of institution, or a change in research direction that requires additional mentoring.
The sponsoring institution must have a well-established research and clinical career development program. It must also have faculty experienced in research on aging and geriatrics to serve as mentors.
The institution must be able to demonstrate a commitment to your development and emergence as a productive, independent investigator.
Mentor(s): Candidates 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 clinically-relevant aging research. 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, minority individuals and individuals with disabilities should be involved as mentors to serve as role models.
The principal investigator and the primary mentor should commit to attending one annual meeting a year as a condition of accepting a BCDA. You should budget funds for your individual travel to and from the annual Beeson meeting for one meeting a year. (The location of the meeting will vary from year to year.)

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 line 11 of the face page of the PHS 398 form.

See also Section 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, starting on page 51.

Note that applications responding to this announcement (new and resubmission) 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.

If you intend to resubmit as a response to this RFA an unfunded application that you submitted in response to RFA AG 07-001, the prior solicitation for the BCDA, then follow the instructions in the PHS 398 form for preparing resubmissions.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: November 18, 2007
Application Receipt Date: December 18, 2007
Peer Review Date: March 2008
Council Review Date: May 2008
Earliest Anticipated Start Date: July 1, 2008

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the Principal Investigator
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIA staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Robin A. Barr, D. Phil.
Office of Extramural Activities
National Institute on Aging
7201 Wisconsin Avenue, Room 2C218, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-9322
FAX: (301) 402-2945
Email: [email protected]

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 must be sent to:

Mary Nekola, Ph.D., Chief
Scientific Review Office
National Institute on Aging
Gateway Building, Room 2C212
Bethesda, MD 20892-9205
Telephone: (301) 496-9666
FAX: (301)402-0066
Email: [email protected]

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

You may submit appendix materials on CD-ROM disks or as hard (paper) copies. If you choose to submit appendix materials as hard copies they should be comprised of unbound materials with separators between documents.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIA. Incomplete and non-responsive 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 review, unless the applicant withdraws the pending application. However, applications submitted in response to the prior solicitation, AG 07-001, but unfunded may be resubmitted to the current solicitation. Follow instructions in the PHS 398 form for preparing resubmissions. Other previously unfunded applications, originally submitted as an investigator-initiated application, that are to be submitted in response to this funding opportunity, should be prepared as NEW applications. That is, the application for this funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application

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.

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

The principal investigator and the primary mentor should commit to attending one annual meeting a year as a condition of accepting a BCDA. You should budget funds for your individual travel to and from the annual Beeson meeting for one meeting a year. (The location of the meeting will vary from year to year.)

As part of a cover letter submitted with the application please indicate whether you will submit your application and the written results of the review (the summary statement) to the American Federation for Aging Research (see Section 2, ii, Funds Available). The cover letter should be signed by the institutional official who signs the face page of the application.

In addition to the Supplementary Instructions in the PHS 398 for Research Career Awards (Instructions, Part III, starting on page 51), the following information must be included in the application:

Candidate

The BCDA program seeks to develop independent investigators and future leaders in the fields of aging research. Describe your commitment to an academic career in clinically-relevant research on aging. Include a description of your professional responsibilities in the grantee institution and elsewhere and show their relation to the proposed activities on the career award:

Present evidence of your ability to interact and collaborate with other scientists.
Discuss your prior training and how it relates to your current objectives.
Describe your past and current research activities including publications, funding, and evolving interests.
Provide any additional evidence of your ability to become an independent investigator and potential leader in the field of aging research.
Include a statement that you will commit at least 75% (nine person-months) effort to the BCDA program. Your department chair (or academic dean) must agree and provide a statement in the application documenting that this amount of your time will be protected.
Provide three sealed letters of reference addressing your potential for a career in clinically relevant aging research. The primary mentor's statement (see below) must not be included as one of the letters of reference.

Statement(s) by Mentors(s)/Consultant(s)/Collaborator(s)

You must name a primary sponsor (or mentor), who, together with you, is responsible for the planning, direction, and execution of the program. You may also nominate co-mentors as appropriate to the goals of the program.
The primary mentor should be recognized as an accomplished investigator in clinically relevant research on aging and have a track record of success in training independent investigators.
The mentors should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
Where feasible, women, minority individuals and individuals with disabilities should be involved as mentors to serve as role models.
The application must include a statement from mentors providing: 1) information on their research qualifications and previous experience as research supervisors; 2) a mentoring plan describing how they will supervise and mentor you during the proposed award period and 3) (for the primary mentor alone) a plan for moving you from the mentored phase of your career to be an independent investigator during the project period of the award. Information on the mentors' active/pending research support related to your research plan should not be included in this statement, but should be provided in the mentor's biographical sketch.
The primary mentor must agree to provide annual evaluations of your progress for the duration of the award as required in the annual progress report, PHS 2590 (see Section VI.3 Reporting).
The primary mentor must provide a statement providing his or her assessment of your potential to become a leader in clinically-relevant aging research.
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 your mentoring.

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 biosketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas 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 your area of interest including a high-quality research environment with staff capable of collaborating with you productively. The sponsoring institution must commit to assisting your development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to you is not contingent upon receipt of the BCDA award.

A letter from a responsible official (department chair or academic dean) at your sponsoring institution should:

Describe the resources and facilities that will be available to you.
Describe how the research environment of the institution is particularly suited to developing your research career on aging and to pursuing your research plan.
In a clear statement, provide assurances that you will be able to devote a minimum of seventy-five percent (nine person-months) of your effort to developing your research program, with any remaining effort being devoted to activities complementary to the BCDA award, and provide release time from normal clinical, teaching or administrative duties.

Candidates who will be using the resources within a General Clinical Research Center (GCRC) or Clinical and Translational Science Award (CTSA) during the course of the award are requested to include a letter of agreement from either the GCRC/CTSA program director or the principal investigator with the application.

Career Development Plan

Describe a systematic plan that shows a logical progression from your prior research and training experiences to the training and research experiences that will occur during the BCDA award period leading to independent investigator status; that justifies the need for further career development and mentoring to become an independent investigator; and that uses the relevant research and educational resources of your institution or other sites. You and your mentor(s) are jointly responsible for preparing the career development plan. A timeline is often helpful. The sponsor/mentor(s) may form an advisory committee to assist with the development of a program of study or to monitor your progress through the career development program.
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 your career goals.

Describe any professional responsibilities/activities (including other research projects and clinical responsibilities) beyond the effort devoted to the BCDA award. Explain how these responsibilities/activities will help ensure that you become an independent investigator in clinically-relevant aging research. Describe any opportunities for leadership that these responsibilities allow.

Training in the Responsible Conduct of Research

You must describe a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instructions in the responsible conduct of research will be considered incomplete and may be returned to you 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 regard the use of human and animal subjects, and data management. Applicants must follow the application instructions found on page 56 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.

Research Plan

Describe 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. Consult with your mentor(s) as you prepare this section. You should describe a sound research project focused on aging and that is consistent with your current research experience and future objectives as conveyed by your career development plan.
Plans for data and safety monitoring must be included in research plans involving Phase I or Phase II clinical trials (see Federal Citations below).

Letters of Reference

Include three sealed letters of reference from well-established scientists with the application addressing the above areas and any other evidence that you have a high potential for becoming an independent investigator and future leader in clinically relevant aging research. The primary mentor's letter of support will be considered independently of the three letters of reference. All unopened letters of reference should be attached to the front page of the application.

Budget for the Entire Proposed Period of Support

The total direct costs requested must be consistent with the amounts described under Funds Available, Section II.2.

Plan for Sharing Research Data

A plan for sharing research data is not required.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (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 NIA 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

The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined by peer review
Availability of funds
Relevance of the proposed program of research and career development to clinically relevant research on aging

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIA in accordance with the review criteria stated below.

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

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

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Candidate
Letters of reference
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 deserve a high priority score. These criteria are listed in logical order and not in order of priority.

Candidate

Do your academic and clinical records show evidence of strong performance and leadership potential?
Does this award advance your potential to emerge as an independent researcher and as a leader in the field of clinically-relevant aging research? Reviewers will consider the proposed duration of support along with the quality of the proposed career development and research activities.
Do you show a commitment to a career in clinically-relevant aging research?

Letters of Reference

Do the letters of reference from three well-established scientists submitted on your behalf support your potential to become an independent investigator and a leader in clinically relevant research on aging? A support letter from your lead mentor will be considered separately from these letters.

Career Development Plan

Likelihood that the career development plan will contribute substantially to your scientific development and lead to your establishing and advancing an independent research career in clinical aging research, based on:

How appropriate are the proposed career development activities to your current experience and expressed goals?
Are your proposed career development activities, research plan and career goals well integrated?
Have you committed at least 75% (nine person-months) effort to the BCDA program? How appropriate are any proposed complementary professional activities to your overall career goals?

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. For candidates who require substantial didactic training as part of their program, the research plan may cover less than the full period of the award.

What is the scientific and technical merit of the research questions, design and methodology?
How will the planned research advance you as an independent researcher?
Does the proposed research contribute to clinically relevant research on aging?

Training in the Responsible Conduct of Research

What is the quality of the proposed training in the responsible conduct of research?

Statement(s) by Mentor(s)/Consultant(s)/Collaborator(s)

How appropriate the qualifications and experience are of all mentors, consultants and collaborators for their proposed roles in this award.

Do your proposed mentors have prior experience and evidence of success in supervising and guiding trainees and junior investigators to research independence in clinically-relevant aging research?
Do your lead mentor and other mentors show evidence of research productivity and funding support for aging research with clinical relevance?
Does your primary mentor's statement support your potential to develop as a leader in clinically-relevant aging research through this award?
Have your mentors, consultants and collaborators committed sufficient time and appropriate effort to your planned didactic and research activities?

Environment and Institutional Commitment

Does your institution clearly allocate a minimum of seventy-five percent (nine person-months) of your effort to activities on the BCDA and provide assurance that any other proposed activities will facilitate your emergence as an academic leader in clinically relevant research on aging?
Are the research facilities appropriate for the work proposed? Are educational opportunities (e.g., appropriate courses) available?
Has the institution successfully developed leading researchers in related fields?
Is there evidence that the institution intends you to be an integral part of its research programs?
Does the institution have a commitment to aging research and resources appropriate for your own activities?

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. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

A data sharing plan is not required.

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 NIA. Program staff may negotiate modifications of the resource sharing plans with the awardee before recommending funding for 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 Principal Investigator will be able to access the 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.

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 these BCDA K08 and K23 awards.

A. Evaluation

In carrying out their stewardship of human resource related programs, NIA, or ODS, may request information essential to assess the effectiveness of this program. Accordingly, you are hereby notified that you may be contacted after the completion of this award for periodic updates on various aspects of your 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. If you currently receive salary and fringe benefit support from an NIH-supported research grant the salary funds from the BCDA will replace your current support. Under most circumstances the funds that are released will be returned to the Institute that supports the other award. However, under unusual circumstances the principal investigator of the other grant may seek approval from that Institute to use the funds for research within the scope of the prior award. If you are supported through an NIH research training grant the slot released when you are appointed to the BCDA will be reassigned by the training director. If you are supported through an NIH career development award the BCDA will replace that award and the remaining funds will be returned to the Institute supporting the terminating award.

C. Special Leave

Leave to another institution, including a foreign laboratory may be permitted if the experience that you propose is directly related to the purpose of your award. Only local, institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of NIA is required. Details on the process for submission of prior approval requests can be founds in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600130.) .

A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the BCDA award will continue during such leave.

Leave without award support may not exceed 12 months. Such leave requires the prior written approval of NIA and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which you are eligible.

Under unusual and pressing circumstances, you may submit a written request to NIA , requesting a reduction in professional effort below 75 percent (nine person-months). Such requests will be considered on a case-by-case basis during the award period. In no case, will it be permissible to work at a rate of less than 50 percent effort (six person-months). The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate other sources of funding (except as described at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html),job opportunities, clinical practice, or clinical training. In each situation, your grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to your scientific development. Further, you must provide written assurance of your intent to return to full-time professional effort (at least 75 percent) 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

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 NIA. 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 NIA staff 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. Termination or Change of Institution

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

If you plan a change of institution, you must submit to NIA in advance of the change a written request for transfer, countersigned by the appropriate institutional business official, describing the reasons for the change and including the new sponsor's name and biosketch when applicable. You must establish in this request 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. Additionally, the new sponsor must have the appropriate research expertise to supervise the program and sufficient research support to ensure continuation of the research program to the end of the award (initial award). Staff at NIA will review this request and may require a review by an initial review group and/or the appropriate national advisory council or board. Upon approval of this request, a new BCDA application must be submitted by the new institution far enough in advance of the requested effective date to permit review. The period of support requested in the new application must be no more than the time remaining within the existing award period.

When a mentor at your grantee institution is to be replaced, the institution must submit a letter from the proposed mentor documenting the need for substitution, the new mentor's qualifications for supervising the program, and the level of support for your career development. The letter must also document that the specific aims of the research program will remain within the scope of the original peer reviewed research program. Staff within NIA will review the request, and will notify the grantee institution of the results of the evaluation.

A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or when an institution relinquishes an award.

3. Reporting

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

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:

Mary Frances Picciano, Ph.D.
Senior Nutrition Research Scientist
Office of Dietary Supplements
National Institutes of Health
6100 Executive Blvd, 3B01
Bethesda, MD 20892-7517
Telephone: (301) 435-3608
FAX: (301) 480-1845
Email: [email protected]

2. Peer Review Contacts:

Mary Nekola, Ph.D.
Chief, Scientific Review Office
National Institute on Aging
Gateway Building, Suite 2C212
Bethesda, MD 20892-2292
Telephone: (301) 496-9666
FAX: (301) 402-0066
Email: [email protected]

3. Financial or Grants Management Contacts:

Linda Whipp
Grants Management Officer
National Institute on Aging
Gateway Building, Suite 2N212
Bethesda, MD 20892-2292
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).

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.

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).

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 RFA 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/.