Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)

Components of Participating Organizations
Office of Research on Women's Health (ORWH), (http://www4.od.nih.gov/orwh/)
National Cancer Institute (NCI), (http://www.nci.nih.gov)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
National Institute on Aging (NIA), (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov/default.htm)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), (http://www.niams.nih.gov/)
Office of Dietary Supplements (ODS), (http://dietary-supplements.info.nih.gov/)

Title: Building Interdisciplinary Research Careers in Women’s Health (K12)

Announcement Type
This is a re-issue of RFA-OD-06-004.

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

• July 22, 2009 - See Notice NOT-OD-09-125 Extension of Receipt Date.

Funding Opportunity Announcement (FOA) Number: RFA-OD-09-006

Catalog of Federal Domestic Assistance Number(s)
93.398, 93.865, 93.866, 93.856, 93.279, 93.242, 93.273, 93.846

Key Dates
Release Date: July 17, 2009
Letters of Intent Receipt Date: August 19, 2009 ( Changed to September 23, 2009 per NOT-OD-09-125 )
Application Receipt Date: September 18, 2009 ( Changed to October 22, 2009 per NOT-OD-09-125 )
Peer Review Date(s): February/March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 1, 2010
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: September 19, 2009 ( Changed to October 23, 2009 per NOT-OD-09-125 )

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. The NIH Office of Research on Women's Health (ORWH) and its cosponsors invite institutional career development award applications for Building Interdisciplinary Research Careers in Women's Health (BIRCWH) Career Development Programs, hereafter termed "Programs." Programs will support mentored research career development of junior faculty members, known as BIRCWH Scholars, who have recently completed clinical training or postdoctoral fellowships, and who will be engaged in interdisciplinary basic, translational, behavioral, clinical, and/or health services research relevant to women's health or sex/gender factors.
• Mechanism of Support. This funding opportunity will use the NIH Institutional Mentored Research Career Development Program Award (K12) mechanism.
• Funds Available and Anticipated Number of Awards. The NIH Office of Research on Women's Health and its cosponsors intend to commit approximately $5 million in total costs [Direct plus Facilities and Administrative (F&A) costs] for this initiative in FY 2010. Up to 10 new and/or competing continuation awards are anticipated.
• Budget and Project Period. The total project period for an application submitted in response to this opportunity may not exceed five years. Direct costs are limited to $500,000 total costs for a five-year period. F&A costs will be included at a standard level of 8%.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/PD/PIs (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
• Number of Applications. Eligible institutions may submit one application.
• Resubmissions. Resubmission applications are not allowed in response to this FOA.
• Renewals. Renewal applications are permitted in response to this FOA.
• Application Materials. See Section IV.1 for application materials.
• Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Career Objectives

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

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

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

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

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

Section VII. Agency Contact(s)
1. Scientific/Research 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

Goals

The goal of this initiative is to increase the number and skills of investigators through a mentored research and career development experience leading to an independent interdisciplinary scientific career that will benefit the health of women, including research on sex/gender similarities or differences in biology, health or disease. Programs will accomplish these goals by ensuring that mentors represent diverse disciplines needed to carry out interdisciplinary projects that will bridge training with research independence for BIRCWH scholars.

Programs must ensure that research projects are interdisciplinary in nature. With increasing understanding of the inter-relatedness and complexity of disease, the nature of scientific investigation is shifting to an interdisciplinary collaborative team approach. Interdisciplinary research could provide an opportunity for not just medical specialties but also researchers in dentistry, pharmacy, nursing, biotechnology, social sciences, anthropology, genetics, and other disciplines, representing different perspectives and areas of expertise, to work together in a mutually beneficial collaboration. Collaborations among research scientists in academia, private industry, and federal settings, could also provide access to the latest scientific tools and technologies for women’s health and sex/gender research.

The new paradigm is that research integrating knowledge from members of the research team who come from multiple disciplines and possess different areas of expertise (for example, physicians, dentists, nurses, pharmacologists, epidemiologists, biotechnologists, social scientists, chemists, physicists, bioengineers and geneticists) is needed to advance women s health. An additional focus on bioengineering and biomedical informatics, genomics, proteomics, imaging, and metabolomics is increasingly relevant to research on women’s health and sex/gender factors.

The NIH Institutes and Centers support biomedical and behavioral research and research training. The Agency for Healthcare Research and Quality (AHRQ) supports health services research and research training. The cosponsors are partnering with ORWH to support the career development of researchers in women's health within their respective missions.

Background

This initiative addresses a continued need for support of interdisciplinary research in women's health. In the "Agenda for Research on Women's Health for the 21st Century, A Report of the Task Force on the NIH Women's Health Research Agenda for the 21st Century," Volume 2, pp. 187-198, Career Issues for Women Scientists, a need was identified for expanded support for interdisciplinary research bridging completion of training with an independent career in research addressing women's health. Also, the report by the Institute of Medicine, "Exploring the Biological Contributions to Human Health: Does Sex Matter?" encouraged interdisciplinary research in sex differences. In 2004, the National Academy of Sciences (N.A.S.) Committee on Facilitating Interdisciplinary Research defined interdisciplinary research as: a mode of research by teams or individuals that integrates information, data, techniques, tools, perspectives, concepts, and/or theories from two or more disciplines or bodies of specialized knowledge to advance fundamental understanding or to solve problems whose solutions are beyond the scope of a single discipline or area of research practice. In addition, a N.A.S. Panel expressed concern at the prolonged time needed to achieve research independence (R01) for Ph.D.s and M.D.s, ages 42 and 44, respectively. This FOA will provide opportunities for a mentored career development experience that would otherwise not be available to help in bridging the transition to research independence for junior faculty researchers who are conducting interdisciplinary research in women's health.

Investigators with established programs covering interdisciplinary basic, translational, behavioral, clinical and health services research in the PD/PI's ("sponsoring") and collaborating departments, centers, or institutes, should form an inter-professional, intellectual and technical research base for mentoring BIRCWH Scholars. Mentors from collaborating departments are encouraged to provide needed expertise and resources, as long as the emphasis of BIRCWH scholars' projects is on research relevant to women's health and is responsive to the research scope identified in this FOA.

Projects may be from a variety of research areas and cut across the boundaries of multiple disciplines but must be within the biomedical and behavioral purview of NIH and/or the health services research purview of AHRQ. Program grant awards resulting from this FOA will meet the specified needs by providing clinical, health or life sciences, or public health departments, centers, and institutes, both developing and established, an opportunity to build a national capacity for junior investigators in interdisciplinary women's health research, including research on sex/gender differences, as well as research on factors that contribute to disparities in health status or health outcomes for different populations of women.

Research Scope

The mission of the Office of Research on Women’s Health (ORWH) is to stimulate and encourage meritorious research on women’s health, including the role of sex and gender in health and disease. Each year, the ad hoc Research Subcommittee of the Coordinating Committee on Research on Women’s Health (CCRWH), composed of representatives from the NIH Institutes and Centers, considers continuing gaps in knowledge, and emerging scientific opportunities for current research priorities in women’s health. The Subcommittee’s recommendations are reviewed and approved by the CCRWH and the Advisory Committee on Research on Women's Health (ACRWH). The priorities signify approaches and areas for which there is a need to stimulate and encourage research on women’s health, or sex/gender factors, and the advancement of women in biomedical research careers.

These research priorities are not an exclusive list of research areas important to women’s health; therefore other innovative or significant research areas should also be considered. Programs may have one or more than one research theme, focus or emphasis, but the research activities must be responsive to this FOA.

I. OVERARCHING THEMES

The following four overarching themes are important for addressing research on women’s health: Lifespan, Sex/Gender Determinants, Health Disparities/Differences and Diversity, and Interdisciplinary Research.

Lifespan: The health of girls and women is affected by developmental, physiological, and psychological age. Women’s lives are marked by a continuum from intrauterine life to the elderly years: infancy, childhood and adolescence, menarche, reproductive life, the menopausal transition, postmenopausal years, the elderly, and frail elderly. Many women’s lives and health status are also influenced by factors such as work inside and outside the home, care-giving such as childcare and elder care responsibilities, reproductive status, marital status, and chronic illness. Each of these may influence health, disease, lifestyle and treatment choices, and response to therapy. Researchers should consider these variables in designing studies related to women’s health.

Sex/Gender Determinants: Women are characterized by both sex and gender as highlighted in the Agenda for Research in Women’s Health for the 21st Century and the Institute of Medicine report, entitled Exploring the Biological Contributions to Human Health: Does Sex Matter? In this context, the term sex refers to being male or female according to reproductive organs and functions assigned by chromosomal complement. Sex factors that contribute to the biological differences include chromosomes, reproduction, and hormones. Gender refers to socially defined and derived expectations and roles rooted in biology and shaped by environment and experience. Gender and sex are important considerations in many areas of research, including basic biological, psychological, social, and behavioral studies. Consideration of these variables may be critical to the accurate interpretation and validation of research affecting the various aspects of women’s health. These variables determine how health or disease processes may differ among women or between men and women.

Health Disparities/Differences and Diversity: Women are disproportionately affected by some conditions and diseases in terms of incidence, diagnosis, course, and response to treatment. Some populations of women may be at higher risk for adverse disease outcomes because of factors such as: biology, genes, culture, education, effects of poverty, access to care, quality of care, and access to opportunities for inclusion as research subjects in clinical trials and studies. Thus, clinical research should include, but not be limited to, population-specific characteristics such as cultural diversity, environmental exposures, race/ethnicity, immigrant status, rural or inner city (urban) residency status, effects of poverty or low socioeconomic status, sexual orientation, and physical or mental disabilities.

Interdisciplinary Research: With increasing understanding of the inter-relatedness and complexity of disease, the nature of scientific investigation is shifting to an interdisciplinary, collaborative approach. Advances in women’s health can be better achieved by promoting partnerships across disciplines. Interdisciplinary approaches can integrate knowledge from multiple specialties and disciplines, thus enhancing the likelihood of defining underlying pathologic processes. Collaborations among researchers in academia, private industry, and federal settings can provide access to the latest scientific tools and technologies and expertise for women’s health research.

II. SPECIAL EMPHASIS AREAS

The NIH is especially interested in fostering research in women’s health in the high priority areas of prevention and treatment, and the biological and behavioral basis of sex and gender differences.

Prevention and Treatment

Increased investigation into methods to prevent conditions and diseases, or to better treat them, can result in significant improvements in the quality and length of women’s lives. Prevention research spans the continuum from the most basic biological studies to examine the basis of both risk and protective factors and behaviors across the lifespan, as well as the interventions to improve them. This includes a focus on communication of wellness and healthy behaviors in health care provider-patient interactions and in public awareness campaigns. Examples of needed prevention and treatment research studies in women’s health include, but are not limited to:

• Research in early detection and treatment, including the development of novel tools to identify and validate biomarkers, including genetic polymorphisms, and RNA expression profiles and functional and morphological brain changes in relation to disease risk, pathogenesis, progression, and to assess their clinical utility for disease prevention;
• Examinations of environmental and social determinants involved in disease initiation and progression to develop prevention and treatment strategies;
• Studies of the impact on health of factors such as alcohol and drug use or abuse, diet, eating disorders, exercise, hormones, obesity, occupations, sex practices, sleep quality, tobacco, environmental exposures, the use of dietary supplements, violence or traumas;
• Development of multi-modal approaches to chronic diseases that contribute significantly to public health disability burden. Examples include addictions, brain injury, cancer, chronic multi-systemic diseases, coronary artery disease, diabetes, neurodegenerative disorders such as Alzheimer’s disease, musculoskeletal disorders, obesity, pain syndromes, sexually transmitted diseases, and stroke; and
• Studies of the effect of biological, behavioral, cultural, economic, environmental, and social factors on susceptibility to, or protection from, disease and response to treatment, and where appropriate sub-set analyses can facilitate personalized medicine.

Biological and Behavioral Basis of Sex and Gender Differences

While there has been much research to identify the function of cellular pathways and genes, research on the effects of sex as a modifier of cellular and gene function is under-investigated. Systemic and cellular modeling of the influence of sex differences in biological pathways and systems is needed, including, but not limited to:

• Mechanisms of sexual dimorphism in gene expression and cellular and signaling pathways in healthy women, including the impact of puberty, the menstrual cycle, pregnancy, and menopause;
• Sexual dimorphism in expression and function of genes, genetic polymorphisms, and gene defects in the risk factors, etiology, severity, and response to treatment of diseases;
• Genetic, molecular and cellular basis of action of pharmacologic agents in women, including differential effects between males and females; and
• Using basic, translational, behavioral, and clinical research approaches, sex and gender differences in the prevention, pathogenesis, course, and response to treatment.

III. AREAS OF RESEARCH INTEREST

Basic, clinical and translational research should be considered in addressing priority areas in women’s health research. Examples may include, but are not limited to:

• Diseases and Conditions that Affect Women. Investigate the pathogenesis and develop preventive and therapeutic interventions for acute and chronic diseases and disorders that affect women including, but not limited to, addiction, autoimmunity, cardiovascular diseases, endocrine, gastrointestinal, inflammatory, metabolic, musculoskeletal, neurological, ophthalmic, oral, psychiatric, reproductive, and urologic diseases.
• Basic and Clinical Research Methodology. Develop clinical trial methodology, including novel recruitment strategies, standardized outcome strategies, and statistical analyses that address ethical and study design issues specific to studies of women. Develop new methodologies for animal model studies of the normal development of women, and their health and diseases, including female animal models. Encourage methodological studies related to the conceptualization, distinction and detection of sex and gender differences in basic and clinical biomedical research. Encourage collaborations between basic scientists and clinicians to identify and test potentially relevant therapeutic approaches.
• Quality of Life. Elucidate the biologic and behavioral factors that may affect women s quality of life, especially elderly women. Develop approaches to management of disease and promotion of wellness that are unique for women, their families and their communities. This could include research examining the unique needs of different populations of women, such as women with disabilities.
• Research Collaborations and Partnerships. Enhance trans-NIH, multi- agency, public-private partnerships, public information partnerships, community-based participatory research in women’s health and career development which promote community-based health communication.
• Career Development and Advancement of Girls and Women in Science. Identify and explore factors that affect the selection and advancement of women’s careers in biomedical sciences; test the effectiveness of novel education programs directed at increasing the participation of girls and women in science and math education; and design and evaluate new approaches to reduce barriers to the sustained advancement and effective mentoring of women to senior and leadership positions in science.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the Institutional Mentored Research Scientist Development Program (K12) award mechanism. The Project Director/PD/PI (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

2. Funds Available

ORWH and cosponsors intend to commit approximately $5 million in total costs [direct plus facilities and administrative (F&A) costs] for this initiative in FY2010; $500,000 in total costs [direct plus facilities and administrative (F&A)] per award.

Up to 10 new and/or competing continuation awards are anticipated;

• Awards maybe up to $500,000 in total costs [up to $100,000 for administrative total costs and up to $400,000 for scholar total costs] annually per award.
• F&A costs will be calculated at 8% of modified total direct costs (exclusive of tuition, fees, and expenditures for equipment).

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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• For-Profit Organizations (Other than Small Businesses)
• State Government
• U.S. Territory or Possession
• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Foreign institutions are not eligible for this award.

Applicant institutions must have the clinical specialties and subspecialties and the clinical and research facilities sufficient to meet the purposes of the BIRCWH program, namely, to bridge clinical or postdoctoral training with a career development program in interdisciplinary basic, translational, behavioral, clinical and/or health services research relevant to women's health.

The FOA is open to new and renewal (competing continuation) BIRCWH programs. A list of institutions that have received a BIRCWH award may be obtained at http://orwh.od.nih.gov/interdisciplinary/bircwhmenu.html.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. An institution may submit only one application in response to this FOA.

Resubmissions. Resubmission applications are not allowed.

Renewals. Renewal applications are permitted in response to this FOA.

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: GrantsInfo@nih.gov.

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.

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

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: August 19, 2009
Application Receipt Date: September 18, 2009
Peer Review Date(s): February/March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 1, 2010

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 PD/PI
• 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 staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Joan Davis Nagel, M.D. M.P.H.
Program Director, Interdisciplinary Research Programs
Office of Research on Women’s Health (ORWH)
National Institutes of Health (NIH)
Department of Health and Human Services (DHHS)
6707 Democracy Boulevard, Suite 400
Bethesda, MD 20892
Telephone: 301-496-9186
Fax: 301- 402-1798
Email: joandav@mail.nih.gov

3.B. Sending an Application to the NIH

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

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

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

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or 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, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the 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 PD/PI 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 NIH Grants Policy Statement.

Allowable Costs

The Program structure may have these elements: Administration Costs (including the Resource Laboratory), Scholar Costs, and Facilities and Administrative (F&A) Costs.

a) Administration Costs: Salary and fringe benefits for the Research Director, if any, up to 10 percent effort, as well as a part-time program assistant may be requested. No compensation may be requested for the PD/PI or mentors. Travel to an annual Directors' meeting for the PD/PI and the Research Director, as well as travel to an annual meeting for current Scholars, both at NIH, must be requested. Travel must also be requested for one additional training or scientific meeting per year for current Scholars.

Resource Laboratory: Budgets may include salaries and fringe benefits for a Resource Laboratory Director (up to 50 percent), other technical staff, supplies, animals, equipment purchase and maintenance. The sum of the budgets for Administration and a Resource Laboratory may not exceed $100,000 total costs per year.

b) Scholar Costs: As part of the Scholars' costs, an application must request a minimum of four BIRCWH Scholar positions at all times, at least half of which must be for individuals with a clinical doctoral degree as defined above in Section A. Requests to have more than four positions will be reviewed by the awarding component in conjunction with ORWH on a case by case basis. If 75 percent salary support for four scholars leaves sufficient K12 funds to support 75 percent of the salary of an additional Scholar, an additional BIRCWH Scholar may be appointed, provided that Institutions can assure that there are sufficient mentoring and interdisciplinary career development resources available to support all scholars. Generally, new scholar appointments will have start dates of January 1, April 1, July 1 and October 1. Scholar appointments should be based on the recommendation of the Advisory Committee.

Salary: This initiative provides support for each BIRCWH Scholar position for up to $100,000 total costs per year. Scholars may be provided salary support of no more than $75,000, which includes any fringe benefits per grantee institutional policy, annually. In addition, research and career development support of up to $25,000 per scholar may be requested (total salary, fringe benefits and research and career development support cannot exceed $100,000 per scholar annually). The institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale from non-federal sources; however, supplementation may not be from federal funds unless specifically authorized by the federal program from which such funds are derived. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the Program. The total salary requested for each BIRCWH Scholar must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure.

Research and Career Development Support: Within each BIRCWH Scholar's total award, up to $25,000 annually may be requested for research and career development support, which may include the following expenses: (1) tuition and fees related to career development; (2) research expenses, such as supplies, equipment, and technical personnel; (3) travel to one training or scientific meeting per year, in addition to the annual NIH meeting for Scholars; (4) statistical services including personnel and computer time; and other project infrastructure including relevant data sets.

Scholars' Other Source of Support: BIRCWH Scholars may not accept or hold any other PHS award that duplicates the provisions of this career award. Scholars are encouraged to apply for independent research grant support during the period of K12 support, and are allowed concurrent salary support only while in the last two years when in compliance with NIH Policy Notice, NOT-OD-04-007 which can be found at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

c) Facilities and Administrative costs: Facilities and Administrative (formerly, indirect) costs will be reimbursed at eight percent of modified total direct costs (excluding tuition, fees, and equipment expenditures), or at the actual Facilities and Administrative cost rate, whichever is less.

Carryover of Unobligated Balances: The K12 award is subject to Expanded Authorities, with the exception of the authority to carry forward funds from one fiscal year to the next. Such carryover must be approved by the Grants Management Branch of the awarding component. An FSR should be submitted annually as part of the progress report.

Non-Allowed Costs

Grant funds may not be requested for the following: compensation for the PD/PI or mentors; direct support of the mentors' laboratories; compensation of administrative personnel normally paid from institutional overhead charges; administrative activities such as public relations, or health or educational services; travel of the PD/PI and Research Director, except for travel to the annual BIRCWH meeting held at NIH, or mentors to scientific meetings; costs of clinical care; and alterations and renovations.

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

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements

BIRCWH Program Requirements

1. Program Director/Principal Investigator (PD/PI): The PD/PI of a Program must be a senior faculty member such as a Dean, Department Chair, or Director of a research center or interdisciplinary institute. He/she should possess the scientific background, leadership, and administrative capabilities required to coordinate and supervise an interdisciplinary research and development program of this scope. The PD/PI of the application may serve as the Research Director (PD with responsibility for the day-to-day operations of the Program). Alternatively, the application may designate a co-investigator other than the PD/PI to serve as Research Director. In that case, the Research Director should be an experienced investigator and have experience and qualifications complementing those of the PD/PI, and the division of responsibility between the two individuals should be clearly described in the application. A PD/PI is allowed to submit one application under this initiative.

2. BIRCWH Scholars: The Scholar position is a junior faculty appointment, not a fellowship. At the time of the award, candidates for support as BIRCWH Scholars must:

• have a clinical doctorate or Ph.D. degree or its equivalent;
• have completed any postgraduate training normally expected for a faculty appointment in their field (including clinical or postdoctoral fellowship training, or residency if they have chosen not to subspecialize);
• have no more than six years of research or research training experience beyond their last doctoral degree;
• identify mentors with extensive research experience;
• be able to spend at least 75 percent (or at least 50% for surgical-specialties) of full-time professional effort conducting research and research career development activities;
• not be or have been a PD/PI on an R01, R29 or subproject of a Program Project (P01), Center (P50, P60, U54) grant, independent mentored career development (K-series) grants, or other equivalent research grant awards; except for R03 and R21;
• be a U.S. citizen or noncitizen national, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-155) or some other verification of legal admission as a permanent citizen. Individuals on temporary or student visas are not eligible.

Generally, new scholar appointments will have start dates four times a year; January 1, April 1, July 1 and October 1. Scholar appointments should be based on the recommendation of the Advisory Committee. Support is in the form of a minimum of two consecutive 12-month appointments, renewable in annual increments up to five years total, and is contingent upon satisfactory progress as reported to the Advisory Committee and to the NIH in the annual progress report of the Program. At least 75 percent (9 calendar months) or at least fifty percent (6 calendar months for surgical specialties such as general surgery, neurosurgery, ophthalmology, orthopedic surgery, plastic surgery etc.) of the BIRCWH Scholars full-time effort must be devoted to the research program of the award. BIRCWH scholars may not accept or hold any other PHS award that duplicates the provisions of this career award. In addition, in keeping with the type of mentoring and career development being provided by the K12, a scholar who is already in the process of applying for an independent mentored career development grant, P01 grant or R01 grant is likely too senior for the BIRCWH.

Programs are encouraged to recruit members of underrepresented racial and ethnic groups, and candidates with disabilities. Scholars are encouraged to apply for independent research grant support during the period of K12 support, and are allowed concurrent salary support only while in the last two years when in compliance with NIH Policy Notice, NOT-OD-04-007 which can be found at:http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

In order to accommodate the needs of those interested in participating in this program that may have had a career hiatus because of family responsibilities, uniformed service, etc., there is no limit on time elapsed since completion of training.

3. Program Composition: Applicants must describe or propose an interdisciplinary career development program that will maximize the use of relevant research and educational resources to foster education, training, mentoring, and professional development of scholars, including members of underrepresented racial and ethnic groups, and candidates with disabilities, in biomedical careers. The Program must have a strong research base, comprising the investigations of established scientists who will provide expertise, resources, and mentoring to the BIRCWH Scholars. The research base must be broad and relevant to current areas of research interest and need in women's health. The environment should be one that will stimulate and increase the interactions among disciplines, which may include basic, behavioral, clinical, social, and population sciences. Of major importance, the Program must have a scientifically sound and equitable procedure for recruiting and selecting BIRCWH Scholars and projects to be supported. There must be documented evidence of an institutional commitment to support the Program's human and tangible resources and its goal of developing and retaining productive, independent investigators in areas of women's health concerns.

4. Mentors: BIRCWH Scholars should be assigned at least two mentors from different disciplines and training background for interdisciplinary research and career development. Additional mentors may be provided as deemed necessary to conduct proposed research project(s). Mentors must be currently funded and recognized as independent investigators who are actively involved in basic, translational, clinical, and/or health services research relevant to this initiative with a track record in mentoring and training of a type expected in this Program. Assigned mentors will interact closely with the scholar and provide guidance to develop a tailored career development plan as part of an interdisciplinary mentoring team. Mentors must be committed to continuing their involvement throughout the BIRCWH Scholar’s total period of development under the award.

5. Career Development Program: The K12 award provides up to five years of funding for the Program. The Program will support BIRCWH Scholars for periods of two to five years consisting of consecutive 12-month appointments. At least 75 percent (or 50% for surgical specialties) of the BIRCWH Scholar's full-time professional effort must be devoted to the K12 program. The remainder of the BIRCWH Scholar's time may be devoted to developing other clinical or academic pursuits consonant with the objectives of the award.

6. Advisory Committee: The Advisory Committee will be a group of scientists from the sponsoring department, and other departments or institutions as appropriate, with interests relevant to the Program's research programs. It may include mentors. The two major functions of the committee are to evaluate: 1) applications from BIRCWH Scholar candidates, and 2) the overall conduct of the Program. Specifically, the committee makes recommendations to the PD/PI as to BIRCWH Scholar appointments, evaluates ongoing research activities annually (including the interaction and integrated nature of the Scholars' research experience), makes recommendations regarding their continuation, and makes recommendations to the PD/PI regarding priorities for use of the Resource Laboratory, if applicable. The committee may use institutional or outside consultants if needed.

Plans to include members or consultants from outside institutions may be described, but such individuals should not be named. The committee is a formal part of the structure of the Program. It should meet regularly, and keep written minutes, which may be reviewed as part of a competing or non-competing application. In addition, an annual evaluation by the Advisory Committee is recommended.

7. Institutional Environment: Applicant institutions should show commitment to the Program's goals, and provide assurances that the institution intends the Program and the supported BIRCWH Scholars to be an integral part of its research endeavor. Research facilities and training opportunities will be a critical part of the environment. Applicant institutions must provide a guarantee of at least 75 percent protected time (or 50% for surgical specialties) for the BIRCWH Scholars for research. As part of its commitment to support women's health research, the applicant institution may choose internally to designate the Program as a Center, supported in part by the K12 Program award. Applicant institutions must demonstrate commitment to recruitment and retention of members of underrepresented racial and ethnic groups, and candidates with disabilities.

8. Resource Laboratory: The laboratory resources of the Program comprise the research laboratories of the established investigators serving as mentors, as well as a shared resource laboratory to be utilized by the mentors and the BIRCWH Scholars whose activities they will supervise. With strong justification, a shared Resource Laboratory may be requested as part of the Program, within the total budget. Such a resource would provide skilled technical services to complement and extend the capabilities of the mentors to promote the career development of the BIRCWH Scholars. The Shared Resource Laboratory might include scientific services such as, but not limited to, assays, molecular biology or biostatistics. Requests for this Resource Laboratory must be justified in terms of cost-effective enhancement of the research resources that will serve at least four BIRCWH Scholars' projects. The salaries and laboratories of the mentors may not come directly from the K12 grant.

The Resource Laboratory, if any, must be a new entity, not an extension or enhancement of an existing facility. The award may support professional direction of the Resource Laboratory, up to 50 percent effort, as well as technical assistance, supplies, equipment, and appropriate costs of operation. Institutional commitment to the shared Resource Laboratory must be demonstrated, and may take the form of providing space, purchase of required equipment, and/or support of personnel. The PD/PI, Research Director and Resource Laboratory Director are responsible for efficient and equitable utilization of the Resource Laboratory on the basis of recommendations from the Advisory Committee.

9. Recruitment Plan: Applicants must submit a plan that describes selection procedures for recruiting scholars. The plan should include a scheme for: (1) recruiting BIRCWH scholars both inside their institution and nationally and (2) recruiting under-served and under-represented racial and ethnic populations and individuals with disabilities.

10. Evaluation Component: For purposes of evaluating the impact of interdisciplinary research career development programs, awardees must agree to provide ORWH with information on how interdisciplinary is being interpreted, implemented and monitored within the institution. There should be a plan for ongoing evaluation of the Program in terms of recruitment and retention goals, including members of underrepresented ethnic and racial groups, and individuals with disabilities, completion success, overall outcome, the curriculum, and program staff.

BIRCWH Application Content and Format Instructions

Applicant Institutions are required to include the following elements in their application:

Program Description: The application must include a description of the activities, such as didactic courses, specialized workshops or tutorials and planned opportunities for cross-fertilization between scholars, which will be incorporated into the career development and mentored research experience of the BIRCWH. The courses should be relevant to diverse areas of women’s health and should address the diversity of the trainees background and research interests. The BIRCWH Program should be designed to accommodate candidates with varying levels of research experience. This individualized design may require career development programs that range between two and five years, depending upon the Scholar.

The instructions in the Form PHS 398 do not fully apply to the special needs of this grant application. Applicants should follow the modified instructions below in preparing an application for the BIRCWH. These instructions have been adapted to accommodate the PHS 398 and this K12 program.

Applicants should refer regularly to those sections of this announcement that delineate "Special Eligibility , Specialized Program Information" and "Review Criteria".

A. Face Page: Use Form Page 1 of the PHS 398. On Line 1, include the title that best represents the nature of the Career Development Program. On Line 2, provide the number of this Request for Applications (RFA-OD-), and the RFA title "Building Interdisciplinary Research Careers in Women’s Health Program (K12)." Complete the rest of the Form Page 1 as directed in the PHS 398 instructions. The abstract description should summarize the actual proposal, including the candidate pool, potential themes or areas of research focus and the overarching goal of the program in terms of career development and the research environment.

B. Description, Performance Sites, and Key Personnel: The information provided under Key Personnel should include the PD/PI, the BIRCWH Research Director, if any, and the mentors. Do not list Advisory Committee members unless they are also mentors.

C. Table of Contents

D. Detailed Budget Page for Initial Budget Period: Budget requests must be provided according to the instructions in form PHS 398. A composite Form Page 4 for the entire Program budget request should be followed by one Form Page 4 for the Scholars' Costs and one Form Page 4 for Administration Costs.

E. Budget for Entire Proposed Period of Support: Provide Form Page 5 for the composite only. The requests for tuition and fees, books, travel, research career development expenses, etc., must be justified and specified by category.

F. Biographical Sketches in the standard NIH format should be provided for all Key Personnel.

G. Other Support should be completed according to the instructions in the PHS 398.

H. Resources page should be completed according to the instructions in the PHS 398.

I. Checklist page should be completed according to the instructions in the PHS 398.

J. The description of the program’s plan (no more than 25 pages). The application must present the program in up to 25 pages (the description of previous progress and tables of current and former scholars are not included in this limit). Applicants are strongly discouraged from giving programmatic URL’s in their applications, and reviewers are not obligated to view applicant’s web sites to review existing public information.

Specialized Program Information should be included as follows:

1) Overview of the proposed program: Summarize the background, and short term and long term career objectives of the program. This description should include a discussion of the strategies to be used to ensure that the objectives of this FOA are met. The description should clearly show how the purpose and objectives meet the broader research priorities identified by the NIH, Office of Research on Women's Health to support the career development of junior faculty who are conducting interdisciplinary research in women's health.

2) Statement by Sponsor: Describe the career development plans for prospective candidates. Considering the Program goals and the likely goals of prospective candidates, describe a plan to provide the necessary research background and experiences, considering the expected range of prior research training in the applicant pool. For example, candidates with little previous research experience may require a phased developmental period in which the first phase of support under this program award may include didactic training in basic and/or clinical research sciences. For these candidates, a second phase would be an intensive, supervised research experience to complete a longer developmental program. More experienced candidates may benefit from entering immediately into a mentored research experience of at least two years supported by this Program award. Other candidates may need to receive concurrent or simultaneous didactic training and a mentored research experience. The application should contain a description of how the career development plan will be tailored to the needs of the prospective candidates.

3) The Scholar Candidates: Describe in general terms the pool of potential candidates including information about the types of prior clinical and research training. Do not name prospective scholars. Describe the criteria to be used for candidate evaluation for selection as BIRCWH Scholars. Describe plans to recruit candidates both locally and nationally, including, racial or ethnic groups that are currently underrepresented in biomedical, behavioral, or clinical sciences, and candidates with disabilities and explain how these plans will be implemented.

4) Advisory Committee: A plan must be provided for the appointment of an Advisory Committee to monitor the progress of the BIRCWH scholars. Describe how the Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies and the recruitment and retention of candidates. A plan for Advisory Committee approval and selection of Scholars should be included. Describe how the Advisory Committee will monitor and evaluate candidates and carry out the evaluation of the overall effectiveness of the career development program.

5) Environment and Institutional Commitment to Candidate: Provide information establishing the commitment of the applicant institution, the PD/PI, and Research Director, if any, and the faculty mentors to providing developmental experiences that lead to independence in biomedical, behavioral, clinical, and/or health services research relevant to women's health. Include the specifics of institutional support. There is no dollar requirement, but significant commitment will be considered strength. Letters from faculty mentors are not required unless they are collaborators from other institutions.

Collaborations between research-intensive and less-research-intensive institutions, and/or minority institutions, will be considered strength.

6) Research Plan: For each faculty member proposed as a potential mentor, provide a paragraph describing the proposed research relevant to the goals expressed in this FOA that may be the foundation of a BIRCWH Scholar s research experience in the Program. The research experiences may include interdisciplinary basic, behavioral, translational, clinical, and/or health services research approaches to biomedical or behavioral problems in women s health. A description should be provided of the approach to mentoring that will be utilized in your program and plans for development of an interdisciplinary mentoring team for prospective scholars. After a review of the NIH/ORWH Research Priorities for 2009, programs may choose to have one or two themes if there is evidence of institutional strength for a particular focus. Lengthy detailed protocols or plans for specific experiments should not be included.

7) Mentors: No limits are specified for the number of proposed mentors; however, fewer than six may not provide sufficient choice of projects, while more than 25 may dilute the focus. In a table, name up to five current or former students or fellows the faculty member has trained, with dates (month/year), where trained, title of project, academic level, and present position and institution. Include a list of currently funded research for each proposed mentor.

Applicants who will be using a General Clinical Research Center (GCRC) are requested to include a letter with the application from either the GCRC Research Director or the PD/PI.

8) Instruction in the Responsible Conduct of Research: Applications must include plans for instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency and duration of instruction, as well as the amount and nature of faculty participation. No award will be made if an application lacks this component.

9) Current BIRCWH Programs: For eligible BIRCWH Programs submitting a competing continuation application in response to this FOA, provide brief summaries of the overall career development program that has been successful in preparing candidates for careers as independent investigators. Include information on the baseline level of entry and career outcomes of all Scholars who have entered your program over the course of the award. The summary should contain information on their research skills acquired, promotions, publications, number of research grant applications submitted (NIH, industry, other), number of research grants funded, honors and awards, and other relevant professional activities. Include measures of success consistent with the nature and duration of the training period, and any additional information helpful in evaluating the impact of your Program.

10) Other K12 Programs: Those institutions with a current Women's Reproductive Health Research Career Development (WRHR) Program or other K12 programs must provide strong evidence that the addition of a BIRCWH Program will provide career development training that is separate and distinct from that offered by their existing K12s, including avoidance of overlap in terms of research topics, budget and related Issues.

11) Evaluation and Tracking Component: The applicant should describe a strong evaluation and tracking plan that will include a review of the effectiveness of all aspects of the program including the diversity of appointed scholars (diversity of backgrounds, disciplines and specialties) and their outcomes (academic placement, NIH funding and types of research being done and its relevance for women’s health), etc.

Appointment of all scholars should be documented by a Statement of Appointment Form (Form PHS 2271) submitted to the ORWH.

12) Instruction in the Responsible Conduct of Research: Every individual supported by a research career development award must receive instruction in the responsible conduct of research. Applications must include a description of plans to provide instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency, and duration of instruction, and the amount and nature of faculty participation. No award will be made if an application lacks this component.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Resource Sharing Plan(s)

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

The following resource sharing policies do not apply to this FOA:

• Data Sharing Plan.
• Sharing Model Organisms.
• Genome Wide Association Studies (GWAS).

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by CSR and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

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

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

The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of the proposed project to program priorities

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).

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

Program Plan:

1) What is the quality of the proposed immediate and long-term career objectives of the Program?

2) Does the PI/PD and Research Director have appropriate scientific and administrative experience in preparing individuals for independent research careers?

3) For institutions with a current WRHR Program or other NIH K12 programs, what is the effectiveness of the plan to keep the career development activities of the proposed BIRCWH Program distinct from that offered by the other K12 Programs, including avoidance of overlap in terms of scholar research topics and justification for the need for the BIRCWH?

4) What is the quality of the plan to provide interdisciplinary research training in women’s health?

Candidate Scholars:

1) Does the application demonstrate an adequate pool of prospective junior faculty, trained locally or recruited from elsewhere who could benefit from receiving research and career development support from the BIRCWH?

2) Is there a well defined selection process to identify, recruit, and select candidates with a commitment to women s health research and the potential to develop as independent researchers?

3) Is there evidence of a scientifically sound and equitable system for evaluating candidates for scholar positions and providing internal quality control of ongoing research?

4) What is the quality of the plan to recruit individuals from racial and ethnic groups underrepresented in research and individuals with disabilities?

Career Development Plan:

1) What is the likelihood that the career development plan will contribute significantly to the scientific development of the candidates? How useful will the program as described be in serving as a vehicle for ensuring interdisciplinary research training in women s health for all BIRCWH scholars.

2) Does the plan include appropriate content for achieving scientific independence for the prospective scholar candidates of different levels of research experience?

3) What is the quality of the training and mentoring in grantsmanship and obtaining of research funds?

Mentors:

1) Does the description of proposed faculty mentors show appropriate qualifications in the areas of research relevant to this FOA? Is evidence of recognition and active involvement in research relevant to women’s health provided?

2) Do the mentors records demonstrate experience in providing guidance to junior faculty and fostering the development of early investigators?

3) What is the quality of the description of the approach to mentoring that will be utilized in the program?

4) Do the proposed mentors records demonstrate the ability to serve as part of an interdisciplinary mentoring team?

Environment and Institutional Commitment:

1) Does the applicant institution demonstrate a commitment to the Program goals and the scientific development of the proposed Scholars e.g. recruitment efforts, salaries and equipment?

2) Have the appropriate assurances been obtained that show evidence that the institution plans to implement the Program and support BIRCWH Scholars as an integral part of its research program?

3) Are there adequate research facilities present at the institution including availability of a General Clinical Research Center, if applicable, and training opportunities, including demonstration of the research base?

4) What is the quality of the environment for scientific and professional development, including opportunities for faculty positions that emphasize research?

5) Does the application as presented demonstrate the applicant institutions commitment to the appropriate balance of research and clinical responsibilities, including a guarantee of the minimum protected time for research for BIRCWH Scholars?

Additional Review Criteria

Reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Instructions in the Responsible Conduct of Research. Does the application include appropriate and adequate plans for training in the responsible conduct of research?

Evaluation/Tracking Plan: Does the proposed plan provide an adequate means to assess the program? Is the system for monitoring Scholars career progression adequate to measure the quality and effectiveness of the Program?

Resource Laboratory (if applicable): What are the nature and quality of the optional new Resource Laboratory, in terms of technical merit, scientific justification, evidence of cost-effectiveness, procedures for quality control, allocation of resources among multiple users, qualifications of the Resource Laboratory Director and technical staff, and probable utility to the research projects of the BIRCWH Scholars?

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

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

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

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

For current BIRCWH programs:

1) What is the quality, overall impact, and effectiveness of the program in training and producing independent women’s health researchers?

2) Is there sufficient evidence of past and current success of the scholars who were/are a part of this program?

3) Does the past performance demonstrate outstanding mentoring capabilities as evidenced by current and past career development programs?

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Additional Review Considerations

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

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

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

Resource Sharing Plans. Not applicable

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information

1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

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

Special Administrative Issues

1. Special Leave: A candidate appointed to this program career award may engage in research experiences at another institution, including a foreign site, if these experiences are directly related to the purpose of the award and within the scope of the scholar's mentoring plan. Only local, institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval of the awarding component is required. To obtain prior approval, the PD/PI must submit a letter describing the plan, countersigned by the appropriate institutional official, to the awarding component. A copy of a letter or other evidence from the performing institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave.

Leave without award support may not exceed 12 months. Such leave will be granted only in an unusual situation. 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 an individual is eligible. Parental leave will be granted consistent with the policies of the NIH and the grantee institution.

2. Termination: The Director of the NIH may discontinue a Program award upon determination that the purpose or terms of the award are not being fulfilled. For a Program co-funded by AHRQ, any such determination would encompass the recommendation of the Administrator of AHRQ. In the event an award is terminated, the Director of the 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. Change of Institution: The Program cannot be transferred from one institution to another.

4. Change of PD/PI and Research Director: Awards are made for a specific Program under the guidance of a particular PD/PI and Research Director, if any. Changes in any of these parameters require prior approval by the awarding component and ORWH under the following conditions:

a) The current PD/PI or the awardee institution has submitted a written request to Staff of the awarding component for change of PD/PI or Research Director, countersigned by the appropriate institutional business official, describing the reasons for the change. The Biographical Sketch of the proposed new PD/PI or Research Director, including a complete listing of active research grant support, is provided. The information in the request establishes that the specific aims of the original peer-reviewed program to be conducted under the direction of the new PD/PI or Research Director will remain unchanged, and that the new PD/PI or Research Director has the appropriate research and administrative expertise to lead the Program.

b) The request is submitted far enough in advance of the requested effective date to allow the necessary time for review.

5. Changes of Program: A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed Program. The new program will be evaluated by the awarding component to ensure that the Program remains within the scope of the original peer-reviewed Program. If the new program does not satisfy this requirement, the award could be terminated.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. 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).

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.

Special Reporting Requirements

Special Reporting Requirements: PHS 2271 appointment form: this form is to be submitted to the awarding IC for each scholar at the time of appointment to the program. Forms are located at: http://grants.nih.gov/grants/forms.htm Any questions should be directed to the Grants Management Office of the awarding IC.

Progress Reports: An Annual Progress Report is required. This report should provide information about changes in the Program, a summary report of the evaluation of the Advisory Committee, a description of the efforts to recruit individuals from diverse populations, including individuals from racial and ethnic groups underrepresented in biomedical research, and individuals with disabilities. Report the research and career progress of each BIRCWH Scholar. These Annual Progress Reports will be closely monitored by NIH staff to ensure that the grant is achieving the goals of the Program.

Progress reports are submitted using the Form PHS 2590, which can be obtained at the following website address: http://grants.nih.gov/grants/funding/2590/2590.htm. Since the Form PHS 2590 does not apply easily to the K12 grant, adapt the application for continuation to contain the following information:

• Appropriate face page (Form Page 1) as instructed in the Form PHS 2590.
• A budget page (Form Page 2) that provides the salary and fringe benefits for each candidate or Scholar by name or by position if no individual is filling the position at the time of the application. Provide all other budgetary information (e.g., supplies, travel, technical assistance) by Scholar name or by the position broken out specifically for each candidate and/or Scholar up to the $25,000 limit.
• A brief description of the Objectives and Goals of the Program
• A brief summary listing by name of any faculty, mentors and Advisory Committee members who have left the Program and those new individuals who have been added or are taking their places. Include for each person their degree and department affiliation (or equivalent).
• Biographical sketches of 1) new mentors, 3) new Advisory Committee Members, and 4) new scholars.
• Progress of Individual BIRCWH Scholars: For each Scholar provide the start date (month/year) of the appointment to the Program and the cumulative number of years supported by the K12 grant; the name of the mentors; and a brief paragraph for each Scholar describing the basic laboratory and/or clinical research and didactic training experiences completed and ongoing. The individual reports should include a list of publications for the Scholar resulting from their work in the program and any pending or received research support in which they are the PD/PI or subproject Director.
• Interdisciplinary Mentoring Team Report. Summarize the approach to mentoring and how the interdisciplinary mentoring team impacted the progress of scholar and their projects.
• A report from the Advisory Committee that is separately attached summarizing the actions of the Advisory Committee during the last year, evaluating the performance of the Program in meeting its objectives and the intent of the ORWH, evaluating the effectiveness of recruitment strategies and providing recommendations for improving the Program (e.g., new mentors, changes in recruitment strategies etc.).
• NIH and non-NIH grants submitted and awarded
• Other information that, from year to year, may be requested by the awarding component to ensure that the grant is achieving the goals of the Program.

Evaluation: In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this Program. Accordingly, K12 scholars should be notified that they may be contacted after the completion of this award for periodic updates on various aspects of the 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.

Final Reports: 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. An evaluation report should be included as part of the Final Progress Report.

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:

Joan Davis Nagel, M.D. M.P.H.
Program Director, Interdisciplinary Research Programs
Office of Research on Women’s Health (ORWH)
National Institutes of Health (NIH)
Department of Health and Human Services (DHHS)
6707 Democracy Boulevard, Suite 400
Bethesda, MD 20892
Telephone: 301-496-9186
Fax: 301-402-1798
Email: joandav@mail.nih.gov

2. Peer Review Contacts:

Dana Jeffrey Plude, Ph.D.
Acting Director, Division of AIDS, Behavioral and Population Sciences
Chief and Scientific Review Officer
Biobehavioral and Behavioral Processes IRG
Center for Scientific Review, Rm. 3176
National Institutes of Health
6701 Rockledge Dr., MSC 7848
BETHESDA MD 20892-7848
(FedEx: 6701 Rockledge Dr., Rm 3176, Bethesda MD 20817)
Phone: 301-435-2309
Fax: 301-435-0014
Email: pluded@csr.nih.gov

3. Financial or Grants Management Contacts:

Bryan Clark, M.B.A.
Chief Grants Management Officer
Grants Management Branch
The Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A01, MSC 7510
Bethesda, MD 20892-7510
(Rockville, MD 20852 for courier or non-USPS service)
Telephone: (301) 435-6975
Fax: (301) 451-5510
Email: clarkb1@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

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

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.

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

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

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

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

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