Department of Health and Human Services
National Institutes of Health (NIH), ( http://www.nih.gov/)
Components of Participating Organizations
National Institute of General Medical Sciences (NIGMS), ( http://www.nigms.nih.gov/)
Title: MARC Undergraduate Student Training in Academic Research, Institutional National Research Service Award (NRSA) Research Training Grant (T34)
This is a reissue of PAR-02-033 as previously released December 6, 2001.
Update: The following update relating to this announcement has been issued:
Announcement (PA) Number: PAR-07-337
Catalog of Federal Domestic Assistance Number(s)
Release Date: March 26, 2007
Letters of Intent Submission Date(s): Not Applicable
Application Submission Date(s): May 25, 2007, 2008, 2009
Peer Review Date(s): October-November
Council Review Date(s): January 2008, 2009, 2010
Earliest Anticipated Start Date(s): June 1, 2008, 2009, 2010
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: May 26, 2009
Due Dates for E.O. 12372
Additional Overview Content
Table of Contents
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
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
1. Research Training Objectives
The overall goal of the NRSA MARC U-STAR program is to increase the number of scientists from underrepresented groups engaged in biomedical/behavioral research. The program will do this by providing support for the research training of undergraduate science/math students from minority-serving institutions to prepare them to pursue Ph.D. degrees and future careers in biomedical and behavioral research.
Purpose and Background Information
The purpose of the NRSA research training program is to help ensure that a diverse and highly trained workforce is available to assume leadership roles related to the Nation’s biomedical and behavioral research agenda. The NRSA program has been the primary means of supporting graduate and postdoctoral research training programs since enactment of the NRSA legislation in 1974. More information about NRSA programs may be found at http://grants.nih.gov/training/nrsa.htm#policy. Research training programs for undergraduates at institutions with a substantial enrollment of students from underrepresented groups were initiated in 1977. The Minority Access to Research Careers (MARC) Branch of the Division of Minority Opportunities in Research (MORE) of the National Institute of General Medical Sciences (NIGMS) seeks to increase the number of researchers from groups underrepresented in biomedical/behavioral research.
MARC U-STAR research training programs are designed to permit the applicant institution to select trainees and develop a curriculum of study and research experiences necessary to provide high quality research training. The MARC U-STAR program provides support for the trainees, who are appointed for the last two years of their undergraduate education, typically called the junior and senior years, to enable them to be fully engaged in the training experience. The MARC program also provides support to enable the institution to improve its educational and research outcomes by strengthening the science curriculum, by providing a variety of student development research training program related activities, and by improving the pedagogical skills of the faculty. The incorporation of interdisciplinary approaches to analyze problems in biological sciences, participation of students in independent library and/or laboratory research, self-directed learning opportunities, the promotion of critical thinking, the implementation of innovative teaching, novel learning strategies, and activities that increase the development of students in the preparation of research careers are examples of activities that could be supported. The MARC U-STAR program should be viewed as a four- or five-year institutional training activity even though financial support to individual trainees is limited to 24 months or the final two undergraduate years.
In 2006, a Working Group of the National Advisory General Medical Sciences Council urged the MORE Division to find ways to increase the numbers of researchers from groups underrepresented in the biomedical/behavioral fields who successfully purse the Ph.D degree by 10% per year. Thus, the MARC Branch seeks a substantial increase above current institutional levels of students progressing to the Ph.D. However, the number of trainee positions requested by an institution should be in balance with the overall strength of the institution’s undergraduate program. The number of baccalaureate students from underrepresented groups in the last five years going on to and completing science Ph.D. programs is an appropriate baseline.
Program Directors are responsible for ongoing evaluation of the quality of the MARC research training program. It is expected that plans will be developed to obtain feedback from former trainees to enhance the program’s outcomes, achieve its goals, and suggest program improvements. All MARC U-STAR applications must describe an evaluation plan for the proposed activities and a tracking plan for trainees in order to assessing program activities/outcomes and to determine the effectiveness of all aspects of their proposed program.
1. Mechanism(s) of Support
This funding opportunity will use the MARC U-STAR Institutional NRSA T34 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed research training program. Awards may be made for periods up to 5 years and are renewable.
This funding opportunity uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application, following the Instructions for preparing an NRSA application.
2. Funds Available
Because the nature and scope of the proposed research training programs 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 NIGMS 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.
Grantees are expected to be familiar with and comply with applicable costs policies and the NRSA Guidelines (http://grant.nih.gov/archive/grants/policy/nihgps_2003/index.htm). Funds may be used only for those expenses that are directly related and necessary to the research training not otherwise available and must be expended in conformance with OMB Cost Principles, the NIH Grants Policy Statement (rev. 12/01/03), and the NRSA regulations, policies, guidelines, and conditions set forth in this document.
Stipends for MARC trainees are provided as a subsistence allowance for trainees to help defray living expenses during the research training experience and are based on a full-time 12-month appointment period. The stipend is not provided as a condition of employment with either the Federal Government or the grantee institution nor is it to be considered a payment for services performed. Stipends will be based on the annual NIH stipend levels at the time of award. The fiscal year (FY) 2007 annual stipend level for MARC trainees is $10,956 (or $913 per month). No departure from the established stipend schedule may be negotiated by the institution with the trainee (see http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-06-026.html for specific information).
B. Tuition and Fees
The NIH will offset the combined costs of tuition and fees at the rate in place at the time of the award. For institutional training grants, an amount per trainee equal to 60% of the level requested by the applicant institution, up to $16,000 per year, will be provided. Costs associated with this category are allowable only if they are required for specific courses as part of the approved research training program and are applied consistently to all persons in a similar research training status at the institution regardless of the source of support. A full description of this new NIH tuition policy can be found in the following link to the NIH Guide: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html.
C. Trainee Travel
Trainee travel to attend scientific meetings and workshops that the institution determines to be necessary for the individual’s research training experience is an allowable expense. Additionally, travel to a research training site away from the institution is expected and support may be requested. MARC U-STAR programs may request per diem funds to help defray the cost of summer housing at an extramural research training site, as well as funds for travel to the extramural site. An institution may request per diem costs equal to the time spent at the extramural site, as well as up to $500 for travel to and from the training site. MARC-supported institutions such as in Puerto Rico or Hawaii that are long distances from the training site may request up to $750 travel expense per trainee, if justified.
D. Trainee Related Expenses (TRE)
The applicant institution may request Training Related Expenses (TRE) to defray costs of curriculum improvement and activities designed to strengthen the pre-freshman, freshman and sophomore pools of potential MARC trainees. This may include the costs of developmental learning, activities for potential trainees, costs for workshops for faculty and travel to workshops, a modest amount of equipment needed to upgrade the curriculum, and the costs of evaluation. However, workshops designed to improve performance on specific tests (e.g., GRE, MCAT) are not allowed, nor is support for only mentoring MARC trainees.
Health insurance for each trainee up to $2,000 (self only or family, as appropriate) may be requested in the Training Related Expenses budget.
E. Facilities and Administrative Allowance
The Facilities and Administration (F&A) allowance for the MARC T34 mechanism is 8% of modified total direct costs, exclusive of tuition, fees, and equipment.
F. Stipend Supplementation, Compensation, and Other Income
A full description of the NIH policy regarding NRSA supplementation and compensation can be found in the NIH Grants Policy Statement at: http://grants1.nih.gov/archive/grants/policy/nihgps_2003/index.htm
Educational Loans or G.I. Bill: An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation.
Acceptance of funds from a PELL grant is allowable as well.
NRSA funds may not be used to provide stipends for non-trainees, including students who may be designated as pre-trainees, nor may funds be used to support more than the awarded number of trainees. Salaries or other benefits in lieu of salaries for trainees or potential trainee participation are not permitted. Recruitment activities are not allowable costs nor are costs for faculty to conduct research or to develop in research. Faculty may not be paid on an overtime or overload basis. Use of a consultant who is also a faculty member of the applicant institution is not permitted.
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application if your organization is a domestic, non-profit, private or public educational institution that offers the baccalaureate degree in a subject related to biomedical and /or behavioral science and has a substantial undergraduate enrollment (as defined by the institution) of students drawn from groups that are underrepresented in the nation’s biomedical and behavioral science research fields. Applications for renewal compete with applications for new awards.
The applicant institution must have the requisite staff and facilities on site to conduct the proposed research training program.
Foreign institutions are not eligible to apply.
1.B. Eligible Individuals
Any full-time faculty member with the skills, knowledge, and resources necessary to carry out the proposed research training program is invited to work with his/her institution to develop an application for support. Typically, a faculty member or administrator with a strong record in research, teaching, and research training and administration and organizational abilities serves as the Program Director of these grant programs. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are always encouraged to apply for NIH support.
The Program Director will be responsible for overseeing the selection and appointment of eligible trainees to the MARC U-STAR grant, for the overall direction, management and administration of the research training program, program evaluation, and the submission of all required forms in a timely manner.
Students appointed to the MARC U-STAR research training program must be students matriculated full-time at the applicant institution in the sciences relevant to biomedicine. Only US citizens or permanent residents are eligible for these traineeships. The primary objective of this program is to increase the number of competitively trained underrepresented students who enroll in and complete highly selective Ph.D. or MD/Ph.D. programs. For purposes of this announcement, underrepresented students are individuals belonging to a particular ethnic or racial group that has been determined by the applicant institution to be underrepresented in the biomedical or behavioral research enterprise of the nation. Nationally, individuals who have been found to be underrepresented in biomedical/behavioral research include, but are not limited to, African Americans, Hispanic Americans, American Indians, and citizens of the U.S. Pacific Islands.
2. Cost Sharing or Matching
Cost sharing is not required.
3. Other-Special Eligibility Criteria
Trainees appointed to the MARC U-STAR research training program must have the opportunity to carry out full-time supervised biomedical or behavioral research with the objective of developing or enhancing their research skills and knowledge as well as their academic preparedness for enrollment in and completion of graduate Ph.D. or MD/Ph.D. programs leading to a future career as a biomedical researcher. Trainees must be full-time students totally committed to the program and its related research training activities consonant with NRSA guidelines which specify that students must commit to a full-time effort, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies.
1. Address to Request Application
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) 435-0714, 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 current PHS 398 research grant application instructions and forms ( http://grants.nih.gov/grants/funding/phs398/phs398.pdf.) Applicants must use the T34 guidelines and the specific instructions for Institutional NRSA Applications, PHS 398, Section IV.;; page limits listed in the PHS 398 apply. 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 on line 2 of the face page of the application form and the YES box must be checked.
3. Submission Dates and Times
See Section IV.3.A for details.
3.A. Submission, Review and Anticipated Start Dates
Letters of Intent Submission Date(s): A letter of intent is not required for this funding opportunity.
Application Submission Date(s): May 25, 2007, 2008, 2009
Peer Review Date(s): October/November
Council Review Date(s): January, 2008, 2009, 2010
Earliest Anticipated Start Date(s): June 1, 2008, 2009, 2010
3.B. Sending an Application to the NIH
Applications must be prepared using the PHS 398 research grant application forms (rev. 4/2006) and the specific NRSA institutional grant application instructions, Section IV of the PHS 398. The Table of Contents must be submitted using the Kirschstein-NRSA Substitute Form Page 3. A categorical budget for the initial budget period of Training Related Expenses must be submitted using the Kirschstein-NRSA Substitute Form Page 4, and the budget for the entire proposed period of support must be submitted using the Kirschstein-NRSA Substitute Form Page 5. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
3.C. Application Processing
Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
Upon receipt applications will be evaluated for
completeness by the Center for Scientific Review. Incomplete applications will
not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.
Information on the status of an application should be checked by the Program Director in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-award costs are not allowable charges for either stipends or tuition on institutional training grants since stipends and tuition costs may not be charged to the grant before the trainee appointment is actually made. However, the policies governing the pre-award cost authority for the expenditure of the other funds provided in a training grant are those permitted in the NIH Grants Policy Statement as follows:
A grantee may, at its own risk and without NIH
prior approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new or competing
continuation award if such costs are necessary to conduct the project, and
would be allowable under the grant, if awarded, without NIH prior approval. If
specific expenditures would otherwise require prior approval, the grantee must
obtain NIH approval before incurring the cost. NIH prior approval is required
for any costs to be incurred more than 90 days before the beginning date of the
initial budget period of a new or competing continuation award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.
The National Research Service Award (NRSA) policies apply to this program. Awards are contingent upon availability of funds. Furthermore, the duration of the award and the number of funded training positions may be less than the levels recommended by the peer review group, based on programmatic and budgetary considerations.
Funds for continuation support beyond the initial year are determined by the success as described in the annual progress report, the timely submission of required forms, and the availability of funds for continuation programs.
Concurrent awards: An NRSA appointment may not be held concurrently with another federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.
Taxability of Stipends: Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-154, impacts on the tax liability of all individuals supported under the NRSA program. Under that section, non-degree candidates are now required to report as gross income all stipends and any monies paid on their behalf for course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization.
The IRS and Treasury Department released regulations in January 2005 (Revenue Procedure 2005-11) clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed by a school, college, or university where the student is pursuing a course of study. Our understanding is that these final regulations do not apply to or impact Kirschstein-NRSA programs or awards. An NRSA stipend is provided by the NIH as a subsistence allowance for Kirschstein-NRSA fellows and trainees to help defray living expenses during the research training experience. NRSA recipients are not considered employees of the Federal government or the grantee institution for purposes of the award. We must note that NIH takes no position on the status of a particular taxpayer, nor does it have the authority to dispense tax advice. The interpretation and implementation of the tax laws is the domain of the IRS.
Individuals should consult their local IRS office about the applicability of the tax laws to their situation and for information on their tax obligations.
Service Payback: No service payback is required for participation in the MARC U-STAR research training grant.
6. Other Submission Requirements
Specific Instructions for Applications
Requesting $500,000 (direct costs) or More per Year.
Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the
IC will accept your application for consideration for award; and,
3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), renewal (type 2), competing supplement, or any revisions or resubmitted version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
Research Training Program: The research training program is expected to provide didactic training in addition to research experiences. A contemporary curriculum rich in quantitative and cross-disciplinary skills is required. The program must develop the skills of potential trainees through a variety of workshops or other interventions. The program is expected to include a plan for determining trainee experience and needs and for monitoring progress to accomplish desired goals. The program must develop trainee skills in understanding research, applying their critical abilities to conduct research, identifying problems in the process of conducting research, raising questions and proposing solutions to resolving problems. Trainees must be prepared to communicate their research findings in writing and orally as they pursue future research training. Programs should provide all MARC trainees with additional professional development skills and career guidance. Examples of strong curricula and skills development may be found on the following NIGMS website under MARC U-STAR Components: http://www.nigms.nih.gov/Minority/MARC .
Applicants also must describe the institutional setting of the training program and define the nature and extent of the participation of students from underrepresented groups in biomedically relevant sciences at the institution. Institutional data must include: 1) the total number of students from underrepresented groups in the participating science departments; 2) the number of honors students from underrepresented groups in the participating departments; 3) the number of junior/senior honors students from underrepresented groups; 4) the number of students from underrepresented groups graduating per year; 5) the number of students from underrepresented groups who enroll in Ph.D. programs; 6) the number of students from underrepresented groups who enroll in professional degree programs; and 7) the number of students from underrepresented groups who participate in post-baccalaureate programs.
Program Director: The Program Director must be a full-time faculty member and must possess the scientific background, leadership, and research training experience and administrative capabilities required to coordinate, supervise, and direct the proposed research training program. The Program Director along with an advisory team of MARC mentors and university administrators will be responsible for the selection, the development and implementation of any proposed curricular changes, as well as the institutional activities to be used to strengthen the pool of potential trainees. In addition, the Program Director will be responsible for the overall direction, management, administration, and evaluation of the program. Program Directors must provide potential trainees information associated with NRSA programs and submit all required trainee forms in a timely manner.
Past Training Record: This section must describe the last five-year research training record of the applicant institution in sending its baccalaureates on to Ph.D. and/or MD/Ph.D. programs in the biomedical and behavioral sciences. Clinical degree programs are not relevant. A renewal application will also describe the past research training record of the MARC program in developing the educational outcomes of potential trainees and trainees. That is, the report must describe the success of former trainees in seeking further career development in the biomedical sciences. It must specifically identify graduate programs, dates of entry and dates of completion. For former trainees currently in graduate programs, contact information for those programs must be provided. An example of how the information can be organized so it is easily interpreted by reviewers can be found in the following sample table.
MARC PROGRAM CUMULATIVE REPORT
Number of trainees slots awarded:
Number of trainees appointed: Junior
Number of trainees appointed: Senior
Number of trainees graduating with BS or BA:
Number of trainees enrolled in Ph.D programs:
Number of trainees enrolled in MD/Ph.D programs:
Number of trainees enrolled in MD programs:
Number of trainees enrolled in MS programs:
Number of trainees in post-bacc programs:
Number of trainees in other professional degree programs:
Number of trainees in teaching positions:
Number of publications by MARC trainees:
For example, the YR1 could be 2001, and YR2 could be 2002, etc. Whether or not an institution chooses to use this table is the choice of the Program Director, but the information requested must be provided with the application.
Trainee Appointments: Appointments are made in 12 month increments with an anticipated total appointment of 24 consecutive months. No trainee may be appointed for less than 12 months during the initial period of appointment, except with prior approval from NIGMS. Appointments are normally made for the last two years of undergraduate education, commonly called the junior and senior years. Trainees should not be appointed unless they plan to complete two years of training. No individual trainee may receive more than two years of aggregate NRSA support at the pre-baccalaureate level. All trainees are required to pursue their research training on a full-time basis, including required coursework and workshops, as specified by the applicant institution in accordance with its own policies. Trainees are expected to spend at least one summer engaged in a research internship at an extramural site. Preferred sites are those research intensive institutions with NIH T32 predoctoral training programs. For the current list of NIGMS T32 grant areas see: http://www.nigms.nih.gov/Training/Mechanisms/NRSA/InstPredoc.
Research Environment/Resources: The applicant institution must have on-site, or through a formal partnership with another university, a high-quality research program in the biomedical science areas proposed for research training and must have the requisite staff and facilities to carry out the proposed program. The application must describe the research environment and resources.
Institutional Commitment: The applicant institution must provide information that documents a commitment to the proposed research training program’s goals and assurance that the institution intends the MARC program to be an integral part of its research and research training endeavor. The application must include a description of support (financial or otherwise) to be provided to the program, which could include support for curriculum implementation, support for additional trainees in the program, space, shared laboratory facilities and equipment, release time for the Program Director and participating faculty, or any other creative ways to improve and enhance the growth of the research training program. While cost sharing is not required, the applicant institution should show that funds for program activities, including financial support for trainees, are not merely being substituted for institutional resources.
Evaluation and Tracking Component: The application must decribe a strong evaluation and tracking component that will review and determine the effectiveness of all aspects of the program. This must include a system for tracking trainees for a 10-year period following their completion of the program to determine success or failure of the program. The follow-up tracking will include information on the career trajectory of trainees who were supported by the program. The application must provide a prospective evaluation plan for process and outcome measures. Outcome measures are expected to be described (for all supported activities) relative to baseline data. The evaluation and tracking report must be included annually as part of the Progress Report. Competing renewal applications must describe the program accomplishments to date, following the application instructions In Section IV of the PHS 398 application (4/2006 rev.) and including the evaluation and outcome measures report described in Section IV.6 (past training record) of this announcement.
Recruitment and Student Development Plan: Applicants must submit a recruitment and development plan for enhancing the pool of potential trainees and a plan for selecting trainees. The application must describe any outreach and advising plans to increase the depth, quality and disciplinary diversity of the applicant pool. It must describe student development activities for potential trainees. In previous announcements, these student development activities were call pre-MARC activities. Continuing student development activities for MARC trainees are strongly encouraged, including service learning such as helping reform science and math education by engaging in partnerships with secondary schools. (For an example of service learning, see Science, November 24, 2006, vol. 314, page 1246.)
Training in the Responsible Conduct of Research: Every NRSA trainee supported by an institutional research training grant must receive instruction in the responsible conduct of research. For more information on this provision, see the NIH Guide for Grants and Contracts, Volume 23, Number 23, June 17, 1994, see: http://grants1.nih.gov/grants/guide/notice-files/not94-200.html . Applications must include a description of a program to provide formal or informal instruction in scientific integrity and ethical principles in research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will not be reviewed.
Plan for Sharing Research Data
Sharing Research Resources
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
2. Review and Selection Process
Applications submitted for this funding opportunity will be assigned to NIGMS.
Appropriate scientific review groups convened in accordance with the standard NIGMS peer review procedures ( http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications:
The following will be considered in making funding decisions:
The goals of NIH-supported research training are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, behavioral, and clinical research needs. The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application. Reviewers will first determine the quality of the proposed research training program and then consider whether the requested number of trainee positions is appropriate for the program.
MARC U-STAR research training applications are evaluated using the following criteria:
Training Program: Are the objectives, design and direction of the proposed research training program appropriate? Does the proposed program provide suitable training for the levels of trainees being proposed and the areas of science to be supported by the program? Are the quality of advising and proposed skills development activities appropriate for pre-MARC trainees and trainees? Are inter- and multi-disciplinary and inter-professional research training opportunities or novel concepts, approaches, methodologies, or technologies appropriately utilized? Does the training plan include required rigorous curricula designed to assure that MARC trainees are prepared for highly selective graduate Ph.D. programs, especially NRSA-supported graduate research training programs? Will having the program lead to an increase in the institutional outcomes of alumni/alumnae earning Ph.D.s?
Training Program Director: Does the Program Director have the scientific background, expertise, and administrative experience appropriate to direct, manage, coordinate, and administer the proposed research training program? Is the time commitment of the Program Director adequate and feasible? Is there an effective team of faculty and staff and administration that assures continuity of the program? Will the program leadership be able to give an appropriate level of effort to the program to ensure the success of its objectives?
Research Mentors: Are the in-house and external mentors of appropriate caliber as researchers and do they have a record of preparing underrepresented minorities for further research? Is there a sufficient number of experienced mentors with appropriate expertise and funding available at the applicant institution or at a partner institution to support a viable program? Is the experience of those providing academic/career advice or workshops appropriate?
Past Training Record: Are the past records of student development at the institution, of research training by the program (if a renewal application), of the Program Director, and of designated preceptors/mentors appropriate? How successful are former trainees in seeking graduate training in highly selective research training programs? Is there evidence of alumni/alumnae completion of Ph.D. programs and progression to further training and research careers?
Institutional Training Environment, Commitment, and Resources: Is the quality of the research environment for the proposed research training program appropriate? Is the level of institutional commitment appropriate? Is the quality of available facilities, curriculum, research and research training support suitable? Is the proposed program to be an integral component of the applicant institution’s overall research program/mission?
Trainee Recruitment, Advising and Selection Plan: Are there appropriate plans for identifying, advising and strengthening potential trainees? Are the recruiting procedures, trainee selection criteria, trainee selection process, and retention strategies appropriate and well defined? Are there advertising plans or other effective strategies to recruit high-quality trainees?
Evaluation and Tracking Plan: Is the evaluation plan adequate and sufficiently detailed to determine changes in institutional outcomes, to track career outcomes of trainees and to determine if the program is successful? Does it include a system for tracking participants following program completion, such as publications, grant proposals and awards, and career trajectory of supported trainees?
2.A. Additional Review Criteria:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398.
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.
Biohazards: If materials or procedures are proposed
that are potentially hazardous to research personnel and/or the environment,
determine if the proposed protection is adequate.
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested period of support will be assessed in relation to the proposed research training program and the number of proposed trainees at the requested levels. The priority score should not be affected by the evaluation of the budget.
Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant’s plan for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.
The plan will be discussed after the overall determination of merit, and the review panel’s evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable, and the result will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. The relevant NIGMS staff will judge the acceptability of the revised plan.
1. Award Notices
After the peer review of the application is completed, the Program Director will be able to access the written critique called a Summary Statement via the eRA Commons.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General ( http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm).
Special Administrative Requirements associated with NRSA programs:
Leave Policies: In general, trainees may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Trainees may receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Trainees may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the program director. A period of terminal leave is not permitted, and payment may not be made from traineeship funds for leave not taken. Trainees requiring periods of time away from their research training experience longer than specified here must seek approval from the NIH awarding component for an unpaid leave of absence. Trainees supported by academic institutions should refer to the NIH Institutional NRSA training grant guidelines at: http://grants1.nih.gov/archive/grants/policy/nihgps_2003/index.htm for further guidance regarding vacations and requested leave.
Part-time Training: While NRSA trainees are required to pursue research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies, under unusual and pressing personal circumstances, a Program Director may submit a written request to the awarding component to change a trainee appointment to less than full-time. Such requests will be considered on a case-by-case basis and must be approved by the awarding Institute in advance for each budget period. The nature of the circumstances requiring part-time training might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission for part-time training will not be approved to accommodate other sources of funding, job opportunities, clinical practice, clinical training, or for other responsibilities associated with the trainee’s position at the institution. In each case, the Program Director must submit a written request countersigned by the trainee and an appropriate institutional business official that includes documentation supporting the need for part-time training. The written request also must include an estimate of the expected duration of the period of part-time training, an assurance that the trainee intends to return to full-time training when that becomes possible, and an assurance that the trainee intends to complete the research training program. In no case will it be permissible for the trainee to be engaged in NRSA supported research training for less than 50% effort. Individuals who must reduce their commitment to less than 50% effort must take a leave-of-absence from NRSA training grant support. The stipend will be pro-rated in the grant award during the period of any approved part-time training.
Carryover of Unobligated Balances: Most of the NIH funding components require prior written approval for carryover of funds from one budget period to the next. When required, such requests must include compelling justification including the status of trainee appointments to the program. If not stated on the Notice of Award, the Program Director should contact the applicable IC’s Grants Management contact to determine the funding IC’s carryover policy.
Termination of Award: When a grantee institution plans to terminate an award, the NIGMS must be notified in writing as soon as possible.
Change of Institution: Awards are made to a specific institution for a specific research training program and the training program may not be transferred from one institution to another. Trainees seeking to change institutions must terminate their current appointment using the Termination Notice (form PHS 416-7, Rev. 10/05), located at http://grants.nih.gov/grants/forms.htm#training.
Change of Training Program Director: If change of a Training Program Director (TPD) is necessary, support of the award is not automatic but may be continued with prior written approval by the NIGMS, provided that the following conditions are met. The current TPD or the grantee institution has submitted a written request for the change, countersigned by the appropriate institutional business official, to program and grants management staff at the NIGMS describing the reasons for the change. The Biographical Sketch of the proposed TPD, including a complete listing of active research grant support, must be provided. The information in the request must establish that the specific aims of the original peer-reviewed program will remain unchanged under the direction of the new TPD and that the new TPD has the appropriate research training and administrative expertise to lead the training program. This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.
Change of Program: A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program. Any change requires prior approval by program staff of the NIGMS If the new program does not satisfy this requirement, the award will be terminated.
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 annual financial statements as required in the NIH Grants Policy Statement. The NRSA program is not subject to SNAP.
The NRSA instructions for the non-competing grant progress report . Section V, Form 2590) should be followed. Note that a substitute budget page and a summary of trainee page are to be included in the request for continuation support. The non-competing application budget page should list the names and levels of those trainees who are continuing in the research training program. Information on each trainee should also be included in the narrative portion of the progress report as described in the PHS Form 2590 instructions.
An evaluation and tracking report as described in Section IV.6. of this announcement should be included annually as part of the Progress Report.
Additional information that should be included in the annual progress report in concert with the PHS 2590 instructions:
Additional Reporting Requirements:
Financial Status Report (FSR): An annual FSR is required and must be submitted within 90 days of the end of each budget period. Continuation support will not be provided until the required form is submitted and accepted.
Trainee Reporting Requirements: The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant. This form must be completed at the beginning of the initial appointment and annually thereafter. If the period of appointment changes, an Amended Statement of Appointment must be submitted. Within 30 days of the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS 416-7, Rev. 10/05) to the NIH. Failure by the grantee institution to submit the 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. Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm.
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, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the research training program.
Final Reports: A final Progress Report and Financial Status Report are required at the end of the grant project period or upon relinquishment of an award. Note that an evaluation and tracking report is required as part of the Final Progress Report.
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:
Chief, MARC Branch
National Institute of General Medical Sciences
45 Center Drive, Room 2AS.37, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3900
FAX: (301) 580 2753
2. Peer Review Contacts:
Helen R. Sunshine,
Chief, Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, Room 3AN.12F, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
FAX: (301) 480-8506
3. Financial or Grants Management Contacts:
Division of Extramural Activities
National Institute of General Medical Sciences
45 Center Drive, Room 2AN.50B, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-5132
FAX: (301) 480-2554
4. Financial or Grants Management Contacts:
Applicants should refer to the ( http://grants.nih.gov/grants/guide/contacts/pa-06-468_contacts.htm) for information for each IC’s grants management contact for this NRSA T32 program.
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals ( http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained ( http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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. Applications that do not provide this information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author’s final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author’s final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors’ Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm
Access to Research Data through the
Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66. 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/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.