Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of Research on Women’s Health (ORWH)
National Cancer Institute (NCI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
Office of Dietary Supplements (ODS)

Funding Opportunity Title

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

Activity Code

K12 Physician Scientist Award (Program) (PSA)

Announcement Type

Reissue of RFA-OD-06-004

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-OD-11-002

Companion FOA

None

Number of Applications

Applicant organizations may submit more than one application, provided that each application is programmatically distinct.  Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.398, 93.865, 93.866, 93.856, 93.279, 93.242, 93.273, 93.846, 93.113  

FOA 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 differences research.     

Key Dates
Posted Date

July 21, 2011

Open Date (Earliest Submission Date)

August 22, 2011

Letter of Intent Due Date

(New Date September 22, 2011 per NOT-HD-11-019), Original Date:August 22, 2011

Application Due Date(s)

(New Date October 21, 2011 per NOT-HD-11-019), Original Date:September 20, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February/March 2012

Advisory Council Review

May 2012

Earliest Start Date(s)

July 1, 2012

Expiration Date

(New Date October 22, 2011 per NOT-HD-11-019), Original Date:September 21, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide especially the Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, except where to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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 differences research.

This FOA encourages applications from organizations that propose creative and innovative institutional research career development programs in the mission area(s) of the NIH.

The proposed institutional research career development program may complement other, ongoing research training and career development programs at the applicant institution, but the proposed career development experiences must be distinct from those career development programs currently receiving Federal support.

Goals

In the past decade, the NIH ORWH has stimulated novel interdisciplinary research through funding initiatives such as the BIRCWH program. 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.

ORWH has long recognized that the study of women's health across the lifespan requires a new interdisciplinary approach to research, bridging basic and clinical science and incorporating new models of collaboration, institutional support, and ways of evaluating those who conduct it.  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 to advance women's health.

ORWH and its co-sponsors intend to provide support for research career development programs that have mentors, environment and programs that will make them particularly effective in enhancing the cadre of junior faculty committed to working across professional and scientific boundaries to address complex conditions that affect women's health. Employing innovative strategies to build a well-trained, diverse and vigorous women's health research workforce are included in the major goals of the NIH Strategic Plan for Women's Health Research: Moving Into The Future with New Dimensions and Strategies: A Vision For 2020 For Women’s Health Research

The NIH Institutes and Centers support biomedical and behavioral 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.

The NIH recognizes a unique and compelling need to promote diversity in the NIH-funded biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; improve the quality of the educational and training environment; balance and broaden the perspective in setting research priorities; improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.  Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups and individuals with disabilities.

The overall goal of the NIH Research Career Development programs is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation’s biomedical, behavioral, and clinical needs.  More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

Background

This initiative addresses a continued need for support of interdisciplinary research in women's health. 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.

A need was identified for expanded support for interdisciplinary research bridging completion of training with an independent career in research addressing women's health in the 1999 NIH Research Agenda for Women's Health and is now increasingly recognized as essential to reduce the fragmentation in women's health care. In addition, the N.A.S., the NIH and other professional bodies have expressed concern at the prolonged time needed to achieve research independence (R01) for Ph.D.s and M.D.s. 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.

To foster the development of a diverse and highly trained workforce of women's health researchers to assume leadership roles related to the Nation's biomedical and behavioral research efforts in women's health, the NIH, ORWH and its cosponsors invite applications for the establishment of career development programs in interdisciplinary basic, translational, behavioral, clinical and health services research in the PD/PI's ("sponsoring") and collaborating departments, centers, or institutes to 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, including research on sex differences as well as research on factors that contribute to disparities in health status or health outcomes for different populations of women.

FY 2011 NIH Research Priorities for Women's Health

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 ORWH works with the NIH Coordinating Committee on Research on Women’s Health (CCRWH), composed of representatives from the NIH Institutes and Centers, to consider continuing gaps in knowledge, and emerging scientific opportunities for current research priorities in women’s health. The recommendations are reviewed and approved by the CCRWH and the Advisory Committee on Research on Women's Health (ACRWH).  Based on the NIH strategic plan released in September 2010, entitled, Moving Into the Future With New Dimensions and Strategies: A Vision for 2020 for Women’s Health Research[i], the FY 2011 NIH research priorities focuses on the key components highlighted within the strategic plan.

Research opportunities are described in terms of overarching themes, special emphasis areas, and areas of research interest.  The priorities signify approaches and areas for which there is a need to stimulate and encourage research on women’s health or sex differences research, 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.

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.

II. SPECIAL EMPHASIS AREAS

The NIH is especially interested in fostering women’s health and sex differences research in the high priority areas outlined in the strategic plan, including:

III. AREAS OF RESEARCH INTEREST

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

ORWH and cosponsors intend to commit approximately $6 million in total costs [direct plus facilities and administrative (F&A) costs] for this initiative in FY2011; $500,000 in total costs [direct plus facilities and administrative (F&A)] per award. Up to 12 new and/or renewal awards are anticipated. .

Award Budget

Awards may be up to $500,000 in total costs direct costs plus facilities and administrative costs (F&A). 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.

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.

Award Project Period

The total project period for an application submitted in response to this opportunity may not exceed five years.    

Other Award Budget Information
Personnel Costs

Individuals designing, directing, and implementing the career development program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. If mentoring interactions and other activities with scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds.

Limited program-related administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when they are in accordance with applicable cost principles.

Administration Costs: Salary and fringe benefits for the Research Director, if any, up to 1.2 person months, as well as a part-time program assistant may be requested. No compensation may be requested for the mentors or PD/PI, unless the PD/PI is also serving as Research Director. 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: With justification, budgets may include salaries and fringe benefits for a Resource Laboratory Director (up to 6 person months), other technical staff, supplies, animals, equipment purchase and maintenance. The sum of the budgets for Administration and a Resource Laboratory may not exceed $65,000 direct costs ($70,200 total costs) per year.  

Participant Costs

Scholars are those individuals who benefit from the proposed activities and experiences involved in the career development program. Scholar costs must be justified as specifically required for the proposed career development program and based on institutional policies for salaries paid to individuals in similar positions, regardless of the source of funds. These expenses must be itemized in the proposed budget:

Salary: Scholars may be provided salary support of $100,000 total costs, plus fringe benefits per grantee institutional policy, annually.  In addition, research and career development support of up to $25,000  total costs per scholar may be requested (total salary, fringe benefits and research and career development support cannot exceed $125,000 total costs 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 total costs 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..

Other Program Related Expenses

Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

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
 
Eligible Organizations

Higher Education Institutions:

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not allowed.

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 BIRCWH programs. A list of institutions that have received a BIRCWH award may be obtained at http://orwh.od.nih.gov/interdisciplinary/bircwhmenu.html.

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program..

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is programmatically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed

Mentors

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.  

Participants

Scholars to be supported by the institutional career development program must be at the career level for which the planned program is intended. Scholars are expected to devote a minimum of 9 person-months during the appointment on the K12 award.

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

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. At least  9 person  months or at l6 person  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. 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.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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 IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, 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(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Joan Davis Nagel, MD MPH
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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for application submission. Follow the instructions in the SF 424 (R&R) Application Guide to determine which components are required.

Page Limitations

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

SF424 (R&R) Other Project Information Component

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) with the following modifications:

Project Summary /Abstract

Provide an abstract of the entire application, including the long-term goals and objectives of the program, key elements of the career development plan, and brief descriptions of planned research projects. Include the rationale and design of the program, the planned duration and projected number of scholars, including their levels (i.e., postdoctoral, faculty).

Mentors Table (Uploaded via the Other Attachments section)

Table of up to 25 Mentors may go here.

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.

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

R&R Budget Component

Follow all instructions provided in the SF424 (R&R) Application Guide with the following modifications:

PHS 398 Research Training Program Plan

All Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application must be followed, with the additional instructions described below:

Substitute all references to “trainees” in the SF 424 (R&R) Application Guide with “scholars” and all references to “training” in the SF 424 (R&R) Application Guide with “career development”.

Program Administration (Component of Program Plan)

Describe the acknowledged strengths, leadership and administrative skills, and scientific expertise of the PD/PI. Include active research and the planned strategy to be used to oversee and monitor the program. For applications with multiple PDs/PI(s), address the Leadership Plan and how the combined knowledge, skills and experience of the individual PDs/PIs will enhance the likelihood of success of the program. The description should clearly show how the purpose and objectives meet the broader research priorities identified by the NIHOffice of Research on Women's Health to support the career development of junior faculty who are conducting interdisciplinary research in women's health. After a review of the NIHORWH Research Priorities for 2011, 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.

When a program administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing investigators must be included in the application 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.

The applicant institution must have a strong and high quality research program(s) in the area(s) proposed under this FOA and must have the requisite faculty and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals. Institutions with existing programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential scholars, and resources are robust enough to support additional programs..

Program Faculty (Component of Program Plan)

Describe the complementary expertise and experiences of the proposed mentors for the scholars. Include active research and other scholarly activities in which the mentors are engaged, as well as track records of mentoring and training. 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. In addition, a description should be provided of the approach to mentoring that will be utilized in your program. BIRCWH Scholars should be assigned at least two mentors from different disciplines and training background for interdisciplinary research and career development  The research experiences may include basic, behavioral, translational, clinical, and/or health services research approaches to biomedical or behavioral problems in women’s health. Of major importance, 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. It is expected that 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.

Proposed Career Development (Component of Program Plan)

Provide an overview of the proposed program: Describe the immediate and long-term objectives of the program, including training or career development activities that will be used to ensure that the objectives of the program are met. Include information about planned courses, curricula, seminars, workshops, or tutorials that will be incorporated into the training program and mentored research experiences and activities. Institutions with existing training or career development programs must explain what distinguishes this proposal from the others, how the programs will synergize, if applicable, and make it clear that the faculty, potential scholars, and resources are robust enough to support additional programs. The description should include planned strategies to be used to ensure that the objectives are met. The PD/PI should also describe past research career development activities/experiences including those of mentors, documenting the success of former scholars in establishing independent productive scientific careers. Programs should provide all scholars with additional professional development skills and career guidance including instruction and training in grant writing in order to apply successfully for future career development and independent research support. All scholars should also be provided with instruction in laboratory and project management. 

Program Evaluation (Component of Program Plan)

Describe an evaluation plan to review and determine the effectiveness of the program. This should include plans to obtain feedback from current and former scholars to help identify weaknesses and to provide suggestions for program improvements, as well as plans for assessing scholars’ career development and progression including degree completion (if applicable), publications, and subsequent positions. Evaluation results should be included in future competing continuation (renewal) applications and as part of the Final Progress Report.

Trainee Candidates (Component of Program Plan)

Describe in general terms the pool of potential candidates including information about the types of prior clinical and research training and career level required for the program. Do not name prospective Trainees. Describe the criteria to be used for candidate evaluation in the selection of Trainees. Describe plans to recruit candidates, including those from economically, socially, or culturally disadvantaged backgrounds, individuals with disabilities or from racial or ethnic groups that are currently underrepresented in biomedical, behavioral, or clinical sciences and explain how these plans will be implemented. Provide brief summaries of training plans that the program will employ. The application should contain a description of how the career development plan will be tailored to the needs of the prospective candidates, taking into account their past experiences and competences, and should distinguish the plan from fellowship training. PDs/PIs should submit a plan for recruiting trainees from both outside and inside the sponsoring institution.

Institutional Environment and Commitment to the Program (Component of Program Plan)

The application must include a statement from the applicant institution describing the commitment to the planned program. The institution must assure that essential time will be allowed for the PDs/PIs, other faculty and mentors, and the required protected time for scholars (9 person months, equivalent to 75%) selected for the program Include the specifics of institutional support. There is no dollar requirement, but significant commitment will be considered a strength. In keeping with ORWH's goal of enhancing research careers, applicants should describe family friendly policies at their institution that support men and women in their science careers..

BIRCWH Application Content and Format Instructions

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

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

Specialized Program Information should be included as follows:

1) Career Development: The application must include a section describing activities that will be undertaken to enhance the talent and career development of junior faculty scholars on the grant including plans for cross-fertilization between scholars, instruction in grant writing in order to apply successfully for future career development and independent grant support, as well as training in leadership skills. 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.

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

2) Resource Laboratory: With strong justification, a shared Resource Laboratory may be requested as part of the Program, within the total budget. Such a resource must be a new entity, not an extension or enhancement of an existing facility. 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. 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.

3) 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.

4) 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.  

5) 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.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

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. .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement. .

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 and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:

All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of 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 program to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Career Development Program and Environment

Does the proposed program clearly outline a plan to recruit and develop well-qualified junior investigators for successful careers as biomedical or clinical researchers? Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support? Are the content and duration of any proposed didactic, training-related, and research-related activities of the program appropriate? Are appropriate timelines indicated for career progression and transition to independence? Does the institutional environment (e.g., research facilities and other relevant resources) in which the program will be conducted contribute to the probability of success? Does the proposed career development program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements? Is the institutional commitment to the proposed program appropriate? If multiple sites are participating, is this adequately justified in terms of the career development and research experiences provided? Is there sufficient assurance that the required effort of the PD/PI, mentors and scholars will be devoted directly to the research training, career development, and related activities? When applicable, is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of input, guidance and oversight of the program?

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

2) 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?

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

4) 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?

5) 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?

Candidate Scholars

What is the quality of plans to identify, recruit, and select candidates, with a commitment to research relevant to the mission of the FOA, and the potential to develop as independent researchers? Is there an appropriate plan for the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence for the prospective candidates? How useful is the research plan as a vehicle for ensuring research training for all scholars as described in the career development plan? What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars? Does the program include a plan to recruit, identify, and select scholars with a commitment to research relevant to the objectives of the FOA? Does the plan for selection of the scholars include all of the eligibility criteria stated in the FOA

Program Director(s)/Principal Investigator(s) (PDs/PIs)

 Do the PD/PI and Research Administrator (if applicable), have the experience to develop, direct and administer the proposed program?  Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives? Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program? Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?

Mentors

Do the mentors have expertise and experience, as well as track records of past mentoring and training? Are the quality and extent of the mentors’ roles in providing guidance and scientific advice to the scholars acceptable? Are the mentors currently engaged in relevant research?

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

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

Training Record

Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training?

Does the program have a track record and success in recruiting scholars and retaining them in research careers?

3) For Renewal applications: Has the program been adequately evaluated and has the level of success been satisfactory?  Do the results of the evaluation document a continued need for support for this program?  Is the approach for the next project period responsive to the results of the program’s evaluation?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

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

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.  

Inclusion of Women, Minorities, and Children 

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period, including on the Recruitment and Retention Plan to Enhance Diversity, and Training in the Responsible Conduct of Research.  Does the application describe the program’s accomplishments over the past funding period(s)?  Are changes proposed that would improve or strengthen the career development experience? Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific careers?

For current BIRCWH programs:

1) What are the quality 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?

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider 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.   

Recruitment & Retention Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel’s evaluation will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

 Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

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).

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

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, scholars are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

The Non-Competing Continuation Grant Progress Report (PHS 2590) and financial statements (Financial Status Report) as described in the NIH Grants Policy Statement are required annually. Continuation support will not be provided until the required forms are submitted and accepted.  The Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, Including Ruth L. Kirschstein National Research Service Awards, must be followed.

Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Other Reporting Requirements

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required  for closeout of an award as described in the NIH Grants Policy Statement...

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Joan Davis Nagel, MD MPH
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

Chyren Hunter, PhD
National Institute on Aging (NIA)
Telephone: 301 494-9322
Email: hunterc@mail.nih.gov

Svetlana Radaeva, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-1189
Email: svetlana.radaeva@nih.gov

Tamara Lewis Johnson, MBA, MPH
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-451-7942
Email: lewisjohnsont@niaid.nih.gov

Bernadette Tyree, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5034
Email: tyreeb@mail.nih.gov

Charisee Lamar, PhD, MPH, RRT
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6977
Email: lamarc@mail.nih.gov

Cora Lee Wetherington, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1319
Email: cwetheri@nida.nih.gov

Carol Shreffler, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1445
Email: shreffl1@niehs.nih.gov

Kathleen M. O'Leary, MSW
National Institute of Mental Health (NIMH)
Telephone: 301-443-3945
Email: olearyk@mail.nih.gov

Rebecca Costello, PhD, FACN
Office of Dietary Supplements (ODS)
Telephone: 301-435-3605
Email: costellb@od.nih.gov

Ming Lee, PhD
National Cancer Institute (NCI)
Telephone: 301-496-8580
Email: leim@mail.nih.gov  

Peer Review Contact(s)

Suzanne Ryan, PhD
Scientific Review Officer
Population Sciences and Epidemiology (PSE) Integrated Review Group
Center for Scientific Review, NIH
6701 Rockledge Drive, Room 3142, MSC 7770
Bethesda, MD  20892-7770 (use 20817 for Fed Ex/delivery)
Telephone:  301-435-1712 
Fax: 301.480.1056
E-mail: ryansj@csr.nih.gov

Financial/Grants Management Contact(s)

Ted Williams
Supervisory Grants Management Specialist (Team Leader)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Grants Management Branch (GMB)
6100 Executive Boulevard, Suite 8A17L, MSC 7510
Bethesda, MD 20852-7510
Rockville, MD  20852 (for express/courier service; non-USPS service)
Telephone: 301-435-6996
Fax: 301-451-5510
E-mail: williate@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


1-  [i] NIH Strategic Plan for Women's Health Research: Moving Into The Future with New Dimensions and Strategies: A Vision For 2020 For Women’s Health Research

2-  NIH Strategic Plan for Women's Health Research: Moving Into The Future with New Dimensions and Strategies: A Vision For 2020 For Women’s Health Research Vol II

3-  Moving Into The Future with New Dimensions and Strategies: A Vision For 2020 For Women’s Health Research Vol III


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