Part I Overview Information 


Department of Health and Human Services

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

Components of Participating Organizations
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov)

Title: MARC Undergraduate Student Training in Academic Research (U-STAR) National Research Service Award (NRSA) Institutional Research Training Grant (T34)

Announcement Type
This is a reissue of PAR-07-337

Update: The following updates relating to this announcement have been issued:

Program Announcement (PA) Number: PAR-10-119

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. Note:  Applications for the MARC U-STAR T34 training grant do not use data tables (Table 1 – 12) as shown on the SF424 Research and Related (R&R) forms.  Instead MARC T34 applicants should use the suggested data tables (Tables A-D) shown in this announcement and downloadable on the MORE/MARC Web site http://www.nigms.nih.gov/Minority/applications.htm.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.859

Key Dates  
Release/Posted Date:  March 3, 2010
Opening Date:  April 25, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s):  Not applicable
Application Due Date(s):  May 25, 2010, 2011, 2012
Peer Review Date(s): October-November
Council Review Date(s):  January 2011, 2012, 2013
 Earliest Anticipated Start Date(s): June 1, 2011
Additional Information To Be Available Date (URL Activation Date): Not applicable
Expiration Date: May 26, 2012

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Academic and Research Training Objectives

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

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

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

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

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

Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations  

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Academic and Research Training Objectives

The primary objective of the NRSA MARC U-STAR training program is to increase the number of highly trained underrepresented biomedical and behavioral scientists in leadership positions who can significantly impact the health-related research needs of the Nation.  To achieve this overarching objective, the program supports the academic preparedness and research training of honors undergraduate science and math majors at minority/minority-serving institutions to prepare students to pursue Ph.D. degrees (or combined degrees like M.D./Ph.D.) in biomedical and behavioral sciences at highly selective graduate institutions. 

Purpose and Background Information: The purpose of the NRSA research training program is to 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 through the NIH Institutional Research Training Grant (T32) mechanism since enactment of the NRSA legislation in 1974.  Research training programs for undergraduates at institutions with substantial enrollments of students from underrepresented groups were initiated in 1977.  The Minority Access to Research Careers (MARC) Branch of the Minority Opportunities in Research (MORE) Division of the National Institute of General Medical Sciences (NIGMS) seeks to increase the number of highly trained scientists from groups underrepresented in biomedical and behavioral research.  As a nation, underrepresented minorities (URMs) include African Americans, Hispanic Americans, American Indians and Alaska Natives and Natives of U.S. Pacific Islands in the biomedical and behavioral sciences …(National Research Council, 2000. Addressing the Nations Changing Needs for Biomedical and Behavioral Scientists. Washington, DC; National Academy Press; and National Science Foundation, Division of Science Resources Statistics, 2002. Characteristics of Doctoral Scientists and Engineers in the United States; 2006 Profile. Arlington, VA; National Science Foundation). NIH legislation acknowledged the national need for minority scientists in the fields of biomedical, clinical, behavioral, and health services research (http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi dbname=106_cong_public_laws&docid=f:publ525.106)

Presently, URMs comprise approximately 29% of the U.S. population but are only 17% of the science B.S. degree recipients and less than 10% of the science Ph.D. degree recipients (NSF Women, Minorities, and Persons with Disabilities in Science and Engineering report).  This underrepresentation of URMs in the scientific workforce is what the MARC U-STAR program is designed to address.  Thus, the MARC Branch seeks a substantial increase above current institutional levels of students going on to the science Ph.D. degree.  

The MARC U-STAR program provides support to honors students who are appointed for the last two years of their undergraduate education, typically called the junior and senior years.  The honors designation is defined by the MARC institution.  In the past, most programs have defined honors by utilizing high GPA as a surrogate. The program is designed to permit an awarded institution to develop a curriculum of study and research training experiences necessary to provide high quality academic and research training.  The grant provides support for a variety of student development activities to both strengthen the science curricula for all students at the institution and provide research training experiences for MARC trainees.  It also supports the cost of stipends, tuition and fees, and health insurance for the appointed MARC trainees in accordance with the approved NIH support levels (see Section II, Allowable Costs).  Some examples of student development activities include, but are not limited to:

Applicants are strongly advised to review the MARC U-STAR Answers to Frequently Asked Questions section on the NIGMS website shown at http://www.nigms.nih.gov/Training/MARC/USTARAwards.htm before they consider applying for the MARC award.

Special Program Objectives and Considerations:  There are seven key features required of MARC undergraduate academic and research training programs.  MARC U-STAR programs must:

1.     Improve their record, from the current baseline, of sending students on to science Ph.D.s.  

2.     Have overall goal(s) and measurable (quantifiable) objectives of the program that are within the framework of the MARC Branch primary objective. 

3.     Have evaluation and assessment tools to determine the program’s overall effectiveness from its baseline. 

4.     Have or develop a synergy with and uniqueness from any and all other science URM student training programs at the institution (e.g., MBRS RISE or IMSD, MORE Special Initiatives Bridges or PREP, NIH T32, NSF LSAMP, HHMI, etc.). 

5.     Have academic training for MARC trainees and other students. 

6.     Provide research training for MARC trainees. 

7.     Have interactions with highly selective graduate institutions, such as those with NIH T32 programs, to send students to competitive science Ph.D. programs. 

See Section 6.A., Special Program Requirements for more details on these requirements.

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the Ruth L. Kirschstein National Research Service Award (NRSA) T34 award mechanism.  Awards may be made for periods up to 5 years and are renewable.

The PD/PI will be solely responsible for planning, directing, and executing the proposed MARC U-STAR academic and research training program.
 
This funding opportunity announcement (FOA) uses the non-modular budget format.  Follow the Instructions for preparing an NRSA institutional research training application described in Section IV, including the PHS 398 Training Budget pages, and the PHS 398 Sub-award Budget Attachment(s) Form (when applicable).  Detailed instructions for completion of the application and Research Training related forms are in the SF424 (R&R) Application Guide for NIH and Other PHS Agencies, Section 8.

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 NIGMS provides support for this program, the total amount awarded and the number of awards will depend upon the number, quality, duration, and costs of the applications received. Applicants are strongly urged to contact appropriate IC scientific staff listed under Section VII for guidance prior to preparing the application.

Grantees are expected to be familiar with and comply with applicable cost policies and the NRSA Guidelines (NIH Grants Policy Statement - Institutional Research Training Grants). Funds may be used only for those expenses that are directly related to and necessary for the academic and research training not otherwise available and must be expended in conformance with OMB Cost Principles, the Ruth L. Kirschstein National Research Service Award (NRSA) Web site.

Tuition and Fees: Applicants should request full needs for tuition and fees.  NIGMS will apply the appropriate formula by offsetting the combined costs of requested tuition and fees at the rate in place at the time of the award.  The rate currently provides 60% of the level requested by the applicant institution, up to $16,000 per year per MARC trainee.  For a full description of the NIH tuition policy, see NOT-OD-10-047.

Trainee Travel:  Travel to attend scientific meetings and workshops that the institution determines to be necessary for the MARC student’s training experience is an allowable and expected expense.  Additionally, MARC trainees are required to spend at least one summer at an extramural site for a research training experience(s).  Preferred sites are those research intensive graduate institutions such as those with NIH T32 training programs.  Foreign sites are not allowed.  The MARC Branch will provide the funds for the summer research experience as follows: $3,000 per MARC trainee, in accordance with MARC institutional policies, to defray the cost of housing and food, which covers a period of ten weeks; an additional $500 for travel to and from the host research training site (for MARC-supported institutions in Hawaii, Guam, Puerto Rico or the Virgin Islands $750 travel expense per trainee will be provided).  NIGMS provides funds for the extramural summer research training experience for up to all of the appointed number of MARC trainees at the time a competing award is made.  However, if an institution has limited or no research capacity, the applicant institution may request funds to send up to 100% of their appointed MARC trainees for the extramural summer research training experience, based on availability of NIGMS funds.

Training Related Expenses (TRE): The applicant institution may request Training Related Expenses (TRE) to help defray costs to conduct the proposed and well justified intervention activities.  Other expenses such as equipment and research supplies for a ‘research classroom’ course(s), staff salaries, faculty/staff travel directly related to the research training program, consultant costs, and program evaluation are also allowed if well justified.  While costs of consultants for evaluation of the program are allowed, if the evaluator is an employee of the applicant institution, the cost must be in the category of key personnel salary on the budget pages.  Further, up to 10% of the overall proposed direct cost of the budget may go towards program evaluation, insomuch as it is well justified. 

Health insurance (self-only or family, as appropriate) for MARC trainees is also an allowable expense that may be charged to the Training Related Expenses budget category but only to the extent that the same health insurance fees are charged to non-Federally-supported students at the applicant institution (see NOT-OD-10-047 for additional information).  Funds are provided as a lump sum on the basis of the predetermined amount per MARC trainee approved for support. 

Under exceptional circumstances, which can include accommodating the disabilities of a trainee, it is possible to request training related expenses to defray such costs.  Requests for additional costs must be explained in detail and justified in the application. Consultation with NIH program staff in advance of such requests is strongly advised (see Section VII).

MARC U-STAR grants do not have budgetary caps.  Note: if requesting over $500,000 per year see Section 6, Other Submission Requirements for pertinent details.  All budget requests must be within the scope of the proposed MARC program and well justified.  With multiple allowable activities related to TRE, it is anticipated that the overall TRE budget may exceed the costs directly related to MARC trainees (stipends, tuition, etc.). 

Facilities and Administrative (F&A) Allowance: Grantees, other than State, local, or Indian tribal governments, will receive F&A costs at 8 percent of modified total direct costs (exclusive of tuition and fees), consortiums in excess of $25,000, and expenditures for equipment rather than on the basis of a negotiated rate agreement. State, local, and Indian tribal government agencies are eligible for full F&A cost reimbursement. For this policy, State universities or hospitals are not considered governmental agencies.

Stipend Supplementation, Compensation, and Other Income: The grantee institution is allowed to provide funds to an individual in addition to the stipends paid by the NIH.  For MARC U-STAR (T34) programs, any supplementation, compensation or other income provided to MARC U-STAR trainees must have prior NIGMS written approval.  Such additional amounts either may be in the form of augmented stipends (supplementation) or in the form of compensation, such as salary or tuition remission for services such as teaching or serving as a laboratory assistant, provided the conditions described below are met.  Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the trainee's approved MARC training program, a consecutive 24 month period.

Supplementation: Grantees may supplement stipends from non-Federal funds provided the supplementation is without obligation to the trainee.  An organization can determine what amount of stipend supplementation, if any, will be provided according to its own formally established policies governing stipend support.  These policies must be consistently applied to all individuals in a similar training status regardless of the source of funds.  Federal funds may not be used for stipend supplementation unless specifically authorized under the terms of the program from which funds are derived.  An individual may use Federal educational loan funds or VA benefits when permitted by those programs.  Under no circumstances may PHS funds be used for supplementation.

Compensation: Funds characterized as compensation may be paid to trainees only when there is an employer-employee relationship, the payments are for services rendered, and the situation otherwise meets all of the conditions and policies in the NIH Grants Policy Statement.  Additionally, compensation must be in accordance with organizational policies consistently applied to both federally and non-federally supported activities and must be supported by acceptable accounting records that reflect the employer-employee relationship. An institution may provide additional funds to a trainee in the form of compensation (as salary and/or tuition remission) for services performed outside of the responsibilities of the full-time NRSA-supported training such as tutoring or serving as a research assistant.  A trainee may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS research grant.  However, compensated services should occur on a limited, part-time basis apart from the normal full-time research training activities. In addition, compensation may not be paid from a research grant that supports the same research that is part of the trainee’s planned training experience as approved in the institutional training grant application.  The MARC PD/PI must approve all instances of employment on research grants to verify that the circumstances will not detract from or prolong the approved 24-month MARC training program.

A full description of the NIH policy regarding NRSA supplementation and compensation can be found in the NIH Grants Policy Statement at: NIH Grants Policy Statement - Part II: Terms and Conditions of NIH Grant Awards.

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.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Only domestic, non-profit, private or public institutions that confer the baccalaureate degree in subjects related to biomedical or behavioral science and that has a substantial undergraduate enrollment of students drawn from groups that are underrepresented in the Nation’s biomedical and behavioral science research fields are eligible to apply.  Foreign institutions are not eligible to apply.   

1.B. Eligible Individuals

Any individual with the skills, knowledge, successful past training record and resources necessary to organize and implement a high-quality academic and research training program is invited to work with their institution to develop an application for support.

The MARC PD/PI should be a full-time faculty member with strong records in research, teaching, training, and administration. The PD/PI will be responsible for the selection and appointment of eligible trainees to the MARC training grant; the overall direction of the program, management and administration of the training program, program evaluation, and the submission of all required forms to NIGMS in a timely manner.

Multiple PD/PIs: More than one MARC PD/PI (or multiple PD/PIs), may be designated on the application for training programs that require a team approach and therefore clearly do not fit the single PD/PI model, e.g., interdisciplinary or multidisciplinary training.  The decision to apply with a single PD/PI or multiple PD/PIs is the responsibility of the investigators and applicant organizations, and should be determined and justified by the goals of the training program.  Applications for grants with multiple PD/PIs require additional information.  When considering multiple PD/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PI will be factored into the assessment of the overall scientific merit of the application.  Multiple PD/PIs on a program share the authority and responsibility for leading and directing the training program, intellectually and logistically.  Each PD/PI is responsible and accountable to the grantee organization for the proper conduct of the program, including the submission of required reports.

Applications with multiple MARC PD/PIs must provide a Leadership Plan that emphasizes how leadership by multiple PD/PIs will benefit the research training program and the trainees. A single Contact PD/PI must be designated for the purpose of communicating with the NIH, although other individuals may contact the NIH on behalf of the Contact PD/PI when necessary.  Because training programs are intended to be coherent a single award will be made.  NIH will not allocate the budget or training positions between multiple PD/PIs.  Multiple PD/PI application should include reasonable numbers of PD/PIs and each should be included for a specific purpose.  Multiple PD/PI applications should not include all mentors of the training grant as PD/PIs, except in unusual cases.

Additional instructional information associated with the multiple PD/PI option is located in Section 8 of the Application Guide instructions 8.10.10 (Multiple PD/PI Leadership Plan).  For background information on the Multiple PD/PI initiative, see: Multiple Principal Investigators.

2. Cost Sharing or Matching

Cost sharing is not required.

3. Other-Special Eligibility Criteria

Trainee Appointments: Appointments are made in 12-month increments, with the duration of the program for each trainee being two consecutive years.  This is done in the final two years of an undergraduate’s tenure (typically called the junior and senior years) for a consecutive 24-month trainee appointment.  On an annual basis, trainee appointments for less than 12 months require prior written approval by NIGMS.

Trainee Citizenship: The individual to be trained must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Noncitizen nationals are people, who, although not citizens of the United States, owe permanent allegiance to the United States. They generally are people born in outlying possessions of the United States (e.g., American Samoa and Swains Island). Individuals who have been lawfully admitted for permanent residence must have a currently valid Permanent Resident Card (USCIS Form I-551) or other legal verification of such status. For example, if an individual has the proper validation on his/her passport, a notarized photocopy of the passport could suffice. Because there is a 6-month limitation on this validation, it is the grantee’s responsibility to follow up and ensure that the individual received the I-551 prior to the 6-month expiration date.

A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving Kirschstein-NRSA support.  Individuals on temporary or student visas are not eligible for Kirschstein-NRSA support. 

Trainees:  Students appointed to the MARC U-STAR academic and research training program must matriculate full-time at the applicant institution in the sciences relevant to biomedicine.   Full-time effort is normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies. Only US citizens or permanent residents are eligible for these traineeships.  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 Alaska Natives, and Natives of U.S. Pacific Islands.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application.  Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons.  All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

The PD/PI should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:  

1) Organizational/Institutional Registration in Grants.gov/Get Registered http://www.grants.gov/applicants/get_registered.jsp http://www.grants.gov/applicants/get_registered.jsp 

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PDs/PIs and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential.  Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number.  Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA); although some of the "Attachment" files may be useable for more than one FOA.  Further, applications for the MARC U-STAR T34 training grant do not use data tables (Table 1 – 12) as shown on the SF424 Research and Related (R&R) forms.  Instead MARC T34 applicants should use the suggested data tables (Tables A-D) shown in this announcement and downloadable on the MORE/MARC Web site http://www.nigms.nih.gov/Minority/applications.htm.

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

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/Apply includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person Profile (Expanded)
PHS 398 Training Budget
PHS 398 Research Training Program Plan
PHS398 Cover Page Supplement
PHS398 Checklist

Optional Components:
PHS398 Cover Letter    

Training Subaward Budget Attachment(s) Form (when applicable)

SPECIAL INSTRUCTIONS  

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in item 14 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Training Plan entitled “Multiple PD/PI Leadership Plan” [Section 8.10 of the Research Training Program Plan], must be included. A rationale for choosing a multiple PD/PI approach should be described.  The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

3. Submission Dates and Times

See Section IV.3A for details.

3.A. Submission, Review and Anticipated Start Dates

Opening Date:  April 25, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Submission Date(s):  Not applicable
Application Submission Date(s):  May 25, 2010, 2011, 2012
Peer Review Date(s): October-November
Council Review Date(s):  January 2011, 2012, 2013
 Earliest Anticipated Start Date(s): June 1, 2011

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

 3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered “on-time”:

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons.  The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays.  All errors must be corrected to successfully complete the submission process.  Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, applications will be evaluated for completeness by the CSR. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the CommonsThe submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check application status in the Commons.

The NIH will not accept any application in response to this FOA 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. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

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 Grants Policy and Guidance.

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.

Pre-Award Costs: Pre-award costs are not allowable charges for stipends or tuition/fees on institutional training grants since these costs may not be charged to the grant until a trainee has actually been appointed and the appropriate paperwork submitted to the NIH awarding component. However, the policies governing the pre-award cost authority for the expenditure of the other funds provided as training-related expense in a training grant are 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 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.

Concurrent Awards: An NRSA MARC U-STAR 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: Section 117 of the Internal Revenue Code applies to the tax treatment of scholarships and fellowships. Degree candidates may exclude from gross income (for tax purposes) any amount used for course tuition and related expenses, such as fees, books, supplies, and equipment, required for courses of instruction at a qualified educational organization. Non degree candidates are required to report as gross income any monies paid on their behalf for stipends or any course tuition and fees required for attendance.

The taxability of stipends in no way alters the relationship between Kirschstein-NRSA trainees and grantee organizations. Kirschstein-NRSA stipends are not considered salaries. In addition, trainees supported under Kirschstein-NRSA institutional research training grants are not considered to be in an employee-employer relationship with NIH or the grantee organization solely as a result of the Kirschstein-NRSA support. Interpretation and implementation of the tax laws are the domain of the IRS and the courts. NIH takes no position on what the status may be for a particular taxpayer, and it does not have the authority to dispense tax advice. Individuals should consult their local IRS office about the applicability of the law to their situation and for information on their tax obligations.

Unallowable Costs:

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

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 NIGMS, MORE 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 MORE staff that the NIGMS will accept your application for consideration for award; and,

3) Include a cover letter with the application that identifies the NIGMS MORE staff member who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing continuation (type 2 renewal), competing supplement (type 3 revision), or any amended or revised (resubmission) version of these grant application types. For additional information on this policy, see: NOT-OD-02-004

6.A. Special Program Requirements

Application Research Training Plan Component Sections

All application instructions outlined in the SF424 (R&R) application, Section 8 are to be followed with the following requirements for T34 applications:

Background and Institutional Environment

Provide rationale for the proposed research training program, relevant background history, and the need for the MARC U-STAR academic and research training proposed.  The Background section should also include information on the institutional environment.  Applicants must describe their institutional setting and show institutional data to include: 1) the total number of students from underrepresented groups in the participating science/math departments, and 2) the number of honors URM students in the participating departments.  These data can be shown using Table A. Institutional Setting.  Applicants are not required to use this table or any other table listed in this FOA; however the information contained in the suggested tables must be presented in the application in some format.  For ease, the tables can be downloaded from the NIGMS/MORE Web site http://www.nigms.nih.gov/Minority/applications.htm.

                   Table A. Institutional Setting

     

Total

Proposed participating MARC departments:

       

Current Number URMs* in proposed participating MARC departments:

       

Current Number Honors*^ URMs  in proposed participating MARC departments:

       

                                                                            Current total number of undergraduate (URM and non-URM) student body:

 

*URM as indicated in MARC-U*STAR FOA      *^ Honors as defined by the applicant institution; typically by Grade Point Average (GPA)

Table B is suggested to show the total number of URM baccalaureate alumni who, in the last five years, have either entered and/or completed biomedically relevant science Ph.D. programs from any institution.  MARC applications must state their total ‘URM Ph.D.’ baseline number in some format; for ease Table B is suggested.  This number, the sum of row 1 and row 2 in suggested Table B, is the baseline value from which the applicant institution wants to grow.  Applicants can determine their ‘URM Ph.D.’ baseline number using, in part, the National Science Foundation’s public database WebCASPAR under the NSF Survey of Earned Doctorates/Doctorate Records File (http://webcaspar.nsf.gov/;jsessionid=4E284DD6BFA8412075E255DA81B03ACC) and the National Student Clearinghouse organization’s public database (http://www.studentclearinghouse.org/).  Additional information may be obtained from records kept at the applicant institution through resources like the Office of the Registrar, Office of Institutional Planning and/or Research, Alumni Office, Office of Institutional Development, Office of Sponsored Programs, etc.  The application must also indicate the number of students from underrepresented groups graduating per year and the number of students from underrepresented groups who completed professional degree (i.e., M.D. degrees) in the last five years.  For M.D. data visit the American Association of Medical Colleges (AAMC) Web site at http://www.aamc.org/.  The number of MARC trainee positions requested by an institution should be in balance with the ‘URM Ph.D.’ baseline number, in addition to the overall strength of the institution’s undergraduate program and the plans for improvement. 

 

Table B. Institutional 'URM Ph.D.' Baseline

YR1

YR2

YR3

YR4

YR5 = Current Year 

Subtotal

1

Number URM* BS/BA alumni who entered biomedically relevant science Ph.D. programs:

           

2

Number URM* BS/BA alumni who completed biomedically relevant science Ph.D. degrees:

           
     

Total URM Ph.D. Baseline Number:       

 

3

Number URM* BS/BA alumni who entered M.D. program: 

           

4

Number URM* BS/BA alumni who completed M.D. degrees:

           
     

Total URM M.D. Baseline Number:

 

*URM as indicated in MARC U-STAR program announcement 
Note:  Biomedically relevant science fields include biology, chemistry, physics, math, engineering, physiology, etc.       

For example, YR1 could be 2006, and YR2 could be 2007, etc. URM students from the applicant institution may have received their BS/BA degree at any time.  Of the alumni, state the number who entered (first row in Table B) and completed (second row in Table B) biomedically relevant science Ph.D. (including those with combined Ph.D. degrees) and then the numbers for M.D. programs and degrees for the last five year period.  The Ph.D. and M.D. degrees can be from any academic institution.  Applicants may footnote using an asterisk any details that require further explanation.

Numerous externally supported science student development programs aimed at increasing representation of URM groups exist.  As such the applicant institution, as a means to further describe its institutional setting, must state the complementarity with and uniqueness from all other such programs on the campus.  Applicants should provide a list of such programs (Table C. Existing Science URM Student Programs may be used) and then in narrative form state how the proposed MARC program will interact with the other programs to leverage efforts and prevent duplication for a synergistic effect.  Conversely, the application must also discuss the differences the proposed MARC program will achieve from the other related programs to show the value-added benefit of the MARC program at the institution.

Table C.
Existing Science URM Student Programs

Program
1

Program
2

Program
3

Program
4

Program
5

Program
6

Program Name:

           

Program Duration (in years) since inception:  

           

Current Project Period Start and End Dates:

           

Funding  Source/Entity:

           

Program Goal:

           

Participant Number:

           

Target URM Audience (academic levels):

           

Program Plan

The MARC Undergraduate Student Training in Academic Research (U-STAR) program is designed to develop students through academic and research training efforts.  MARC U-STAR applications must provide the overall goal(s) and quantifiable objectives of the proposed plan that focuses on academic and research training and is within the framework of the MARC Branch’s primary objective.

a.     Program Administration—Training Program Director/Principal Investigator (PD/PI):  The MARC PD/PI must be a full-time faculty member at the applicant institution who possesses the scientific background, leadership, training experience, and administrative capabilities required to coordinate, supervise, and direct the proposed training program.  The PD/PI along with an advisory committee comprised of MARC faculty and university administrators will be responsible for selection, development, and implementation of proposed academic and research activities. Plans should describe how the MARC PD/PI will interact with NIGMS T32 PD/PIs to encourage MARC students to attend such institutions for the required summer extramural research training experience and apply for Ph.D. programs at these highly selective graduate institutions.  To assist with this interaction, NIGMS has created a Web-based resource called the Community for Advanced Graduate Training (CAGT), for details visit https://cagt.nigms.nih.gov/. Taken together, the Program Director will be responsible for the overall direction, management, administration, and evaluation of the program.   

If multiple PDs/PIs are involved in the training program, applicants must describe how the research training program and trainees will benefit from this arrangement.  A Leadership Plan is required.  See Section III.1.B in this FOA, NIH multiple PD/PI instructions: Multiple Principal Investigators, and information in Section 8.7.10 of the PHS 398 Research Training Program Plan Component Instructions.

b.     Program Faculty—Preceptors/Mentors: The application must include information about the program faculty who will be available to serve as preceptors/mentors and provide guidance and expertise to the level of trainees proposed in the application. The preceptors/mentors should have strong records as researchers and experience mentoring undergraduates, especially underrepresented minorities.  For the required extramural summer research training component, several letters agreeing to mentor MARC trainees from host external institution(s) along with biographical sketches of potential faculty preceptors/mentors should be included in the application.  If a program proposes an academic-year internal research training component, then biographical sketches of several MARC faculty preceptors/mentors from the applicant institution should be included in the application.

c.     Proposed Training: The MARC U-STAR training grant application must show what academic training students will undergo to be competitively trained to enter science Ph.D. programs at highly selective graduate institutions. A contemporary science curriculum rich in quantitative and cross-disciplinary skills is required (see http://www.nap.edu/openbook.php?isbn=0309085357).  The MARC grant enables the institution to improve its educational outcomes of all students (not just those participating in the MARC program) by strengthening the science curriculum.   The MARC Branch’s former RFA entitled MARC Curricular Improvement, while no longer active, may be used as a guide or for instructional purposes for proposing curricular reform under this FOA (see http://grants.nih.gov/grants/guide/rfa-files/RFA-GM-06-005.html).  Further, faculty pedagogical skills training is encouraged to enhance the academic learning environment at the institution.  Faculty could employ modern teaching modalities that confer improved learning outcomes (see http://www.asbmbtoday-digital.com/asbmbtoday/200909/?pg=42#pg42 for details).  The grant enables faculty to attend workshops, seminars, etc. to acquire the knowledge and skills necessary for improved pedagogy (for example see http://dels.nas.edu/summerinst/index.shtml regarding the National Academies Summer Institution on Undergraduate Education in Biology).

To meet the objective of achieving science Ph.D. degrees, the MARC program must also facilitate the development of a trainee’s research skills, such as the ability to apply critical thinking to conduct research, identify problems in the process of conducting research, raise questions and propose solutions to resolve research problems, and communicate  research findings orally and in writing.  All MARC programs, regardless of the research capacity/external grant support, must provide at least one external summer research training experience for MARC students. The MARC Branch will provide a summer research per diem to offset costs (see Section 2.A, Allowable Costs).  The external research institutions are preferably those with NIH T32 grants such that MARC students can get a sense of the research culture on a highly selective graduate campus. 

d.     Training Program Evaluation: The application must describe an evaluation plan to determine the quality and effectiveness of the training program. The plan must provide useful information to the PDs/PIs and the institution for improving the MARC program. Thus, the emphasis of the evaluation activities should be on (a) assessment of the overall impact of the program on the institution’s baseline numbers and efforts to accomplish its proposed goal of students who complete Ph.D. degrees in biomedical and/or behavioral sciences, (b) improvement of the overall program outcome, and (c) informing the senior leadership in deciding which elements of the MARC program should be institutionalized.

The plan should identify the selected evaluator and present his/her credentials. In general, the evaluator must have formal training and experience in evaluation methodology and statistics, which is demonstrated by publications and/or reports in the field.  His/her responsibilities typically include preparing reports and making recommendations  to the PDs/PIs and institutional administrators; establishing and maintaining contact with institutional officials for the collection and exchange of information; gathering data and information;  finding and evaluating alternative solutions, etc.  Use the appendix to include the evaluation instruments as a single document in the application. 

e.     Trainee Candidates: The application must describe the recruitment plans, including the sources and availability of trainees; the qualifications of prospective trainees; and the criteria and procedures by which trainees will be selected.  Activities to increase the depth, quality, and science disciplinary diversity of the applicant MARC trainee pool are encouraged and must be described.  Such efforts should interest and motivate pre-freshmen, freshmen, and sophomores at the institution.

Past MARC Trainee Record: 

For applicants with a former MARC U-STAR training program the competing renewal application must describe the past MARC trainee record over the previous years.  Table D (shown below) may be used to describe MARC trainee outcomes.  The total number of appointed trainees in a given year must add up with the other categories for that cohort.  Where applicable, include the total number of MARC alumni who earned biomedically relevant science Ph.D. degrees in the past 10 years.

Table D. Past MARC Trainee Record       

YR1

YR2

YR3

YR4

Current
Year
YR5

Total

Number of trainee slots awarded:

           

Number of trainee slots appointed:

           

    Number of Junior level trainees appointed:

           

Number of Senior level  trainees appointed:

           

Number of trainees who left MARC program:

           

Number of trainees who graduated with BS or BA:

           

Number of trainees enrolled in Ph.D or combined programs:

           

Number of trainees enrolled in M.D. programs:

           

Number of trainees enrolled in MS programs:

           

Number of trainees in post-bacc programs:

           

Number of trainees in other activities:

           
 

In the last 10 years, number of MARC alumni who earned a science Ph.D.(or combined)

 

f.      Institutional Commitment and Resources: Institutional commitment to the proposed MARC program must be demonstrated in the proposal. While cost sharing is not required applicants must include a description of support from the institution (financial and otherwise) to be provided for the proposed program.  This could include, for example, space, shared laboratory facilities and equipment, funds for curriculum development, release time for the PD/PI and/or participating faculty, or any other creative ways to improve the climate for the establishment and growth of the MARC academic and research training program.  Above all, MARC funds, including those providing support for student fellowships, should not be substituted for other institutional sources.

Training in the Responsible Conduct of Research

Every trainee supported by this training grant must receive instruction in the responsible conduct of research. All Applications must include a plan to provide such instruction. The plan must address five components: format; subject matter; faculty participation; duration of instruction; and frequency of instruction as detailed in NOT-OD-10-019.  Renewal (Type 2) applications must, in addition, describe changes in formal instruction over the past project period and plans for the future that address any weaknesses in the current instruction plan.  All training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.  Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process.  The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019.   

Select Agent Research

If participating faculty proposed in the training program are conducting or plan to conduct research involving select agents in which trainees may participate, follow the instructions in SF424, Section 5.5, and include information in PHS398 Research Training Program Plan, Item 9, Select Agent Research.

6.B. Resource Sharing Plans  

Not Applicable.

6.C. Data Tables

Applications for the MARC-USTAR T34 training grant do not use SF424 Research and Related (R&R) form data tables (Table 1 – 12).  Instead MARC T34 applicants may use the suggested data tables (Tables A – D) shown in this FOA. While applicants are not required to use the suggested Tables A-D, the information contained on them must be presented in the application in some format.  For ease, the tables can be downloaded from the NIGMS/MORE Web site http://www.nigms.nih.gov/Minority/applications.htm.

6.D. Appendix Materials

Do not use the appendix to circumvent the page limitations of the Training Plan.  MARC data Tables A-D shown in this FOA are exempted from the page limits and should be grouped separately after the Research Plan and before the appendix. 

A summary listing all of the items included in the appendix is required, and should be the first PDF file. Applications that do not follow the appendix requirements may be delayed in the review process. All appendix material must be submitted as PDF attachments.

Research publications of trainees and mentors are not normally included as part of the Training Grant applications, but are allowed.  Other types of publications reflecting on the activities of the program as a whole may also be included.  When publications are allowed, appendix materials should be limited to those which are not publicly available, such as:

Do not include unpublished theses or abstracts/manuscripts submitted, but not yet accepted, for publication. 

Publications that are publicly accessible must not be included in the appendix. For such publications, the URL or PMC submission identification numbers along with the full reference should be included as appropriate in the Bibliography and References Cited/Progress Report Publication List section of the Research Plan, and/or in the Biographical Sketch.

Some materials other than publications that are unique to training grant applications (but not typically included in research grant applications) may be included as appendices.  The appendix may be used to provide samples of materials that are referred to in the body of the application, but are too cumbersome to include in the Training Program Plan without disrupting the narrative flow.  Examples include:

i)      Additional tables not requested in the SF424 instructions – designate these by letter, rather than number, to avoid confusion with the numbered required tables;

ii)     Syllabi for key courses, core courses and electives, including courses in Responsible Conduct of Research, Survival Skills for Research, etc.;

iii)    Retreat, seminar series, and other program activity agendas, rosters, and schedules;

iv)    Examples of forms used to document trainee progress and monitoring by the program;

v)     Examples of materials used in recruitment and particularly recruitment and retention to enhance diversity of the student pool;

vi)    Lists of meetings attended by students and their presentations;

vii)   Student biosketches; and

viii)  Letters of support, collaboration, and commitment of institutional resources.

For materials that cannot be submitted as a PDF attachment, applicants should contact the Scientific Review Officer for instructions following notification of assignment of the application to a study section. Applicants are encouraged to be as concise as possible and submit only information essential for the review of the application.

 Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

Review Process

Appropriate scientific review groups convened by NIGMS in accordance with the standard NIH 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 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, including information presented in the data tables and appendix, and then consider whether the requested number of trainee positions is appropriate for the program. 

Overall Impact:

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the training program to exert a sustained, powerful influence on sending URMs to highly selective science Ph.D. programs, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the research training program proposed). 

Scored Review Criteria: 

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

Training Program and Environment:  How will the academic and research training program lead to an increase (over the current URM Ph.D. baseline) in the number of URM students at the institution completing science Ph.D. degrees?  What is the quality of the academic and research training environment in preparing students for successful careers in biomedical sciences?  What is the evidence that MARC trainees and other students will take a strong curriculum and participate in skill-building activities that prepare them for graduate training?  What will be the purpose and added value in having the proposed MARC program at the institution, especially if other student development programs with similar objectives exist?  Is the quality of advising and proposed skills- development activities appropriate for MARC trainees and other students to be able to thrive in graduate (Ph.D.-level) school?  What is the level of institutional commitment to meet the program’s goal(s)?

Training Program Director/Principal Investigator (PD/PI): Does the Program Director have the scientific background, expertise, and administrative experience appropriate to direct, manage, coordinate, and administer the proposed academic and research training program?  What is the evidence that the PD/PI is likely to provide a high-quality training program?  What is the evidence that the PD/PI will be able to affect institutional change (e.g., academic) for improved student outcomes?  How does the PD/PI demonstrate the ability to work effectively with staff, administrators, and faculty both at the proposed MARC institution and with individuals at host institutions for summer research and graduate (Ph.D. level) training?

Preceptors/Mentors and Other Staff:  Are the examples of external and internal (where proposed) mentors of appropriate caliber as researchers and do they have a good record of training undergraduates from underrepresented minority groups?  What is the evidence that MARC preceptors/mentors will be informed of program expectations and their role?  If the plan includes intramural research training through ‘research classroom’ course(s), what is the evidence that effective research training will be provided by the faculty and staff? What is the experience of faculty and/or staff in providing academic and career advice?  What is the role of the program coordinator and is there evidence that this person will be successful? 

Trainees: What is the quality of the plans for identifying, advising and strengthening potential MARC honors trainees?  Are the recruiting procedures, trainee selection criteria, trainee selection process, and retention strategies well defined?  What is the evidence that MARC trainees will be informed of program expectations and their roles? 

Training Record: How good is the past five-year record of the institution in sending URM alumni on to biomedically related Ph.D. degrees?  What is the evidence that the proposed plan will be an improvement over this past training record?  Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training?  Are effective mechanisms in place for obtaining feedback from current and former trainees and monitoring trainees’ subsequent career development?  How will the evaluation plan determine if the program is effective in meeting its objectives?  For competing renewal applications: Does the application describe the program’s accomplishments over the past funding period?  How much improvement has there been in the institution’s ability to send URM students to science Ph.D. programs since the last competing application?  Are changes proposed that would improve program performance based on evaluation and assessment outcomes?

Additional Review Criteria:

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

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

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

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

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

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

Resubmission Applications: When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

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

Revision Applications: When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident

Additional Review Considerations

Training in the Responsible Conduct of Research: Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable.  Reviewers will specifically address five Instructional Components (Format, Subject Matter, Faculty Participation, Duration and Frequency), taking into account the characteristics of institutional programs or the unique circumstances for short-term training programs, detailed in NOT-OD-10-019.  The review of this consideration will be guided by the principles set forth in NOT-OD-10-019.  Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE. Applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan.

Select Agents Research: When applicable, 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: 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 impact/priority score should not be affected by the evaluation of the budget.

Selection Process

The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the Training PD/PI 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 may l request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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 (NIH Grants Policy Statement) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (NIH Grants Policy Statement).

Institutional NRSA training grants must be administered in accordance with the current NRSA section of the NIH Grants Policy statement at NIH Grants Policy Statement - Institutional Research Training Grants, and any terms and conditions specified in the NoA.

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 60 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 this level of paid leave for this purpose and the use of parental leave is approved by the Training PD/PI (see NOT-OD-08-064).  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: NIH Grants Policy Statement 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 pressing personal circumstances, a MARC PD/PI may submit a written request to NIGMS 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 NIGMS 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 PD/PI 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.  Part-time training may affect the rate of accrual or repayment of the service obligation for postdoctoral trainees. 

Carryover of Unobligated Balances: NIGMS requires prior written approval for carryover of funds from one budget period to the next for MARC U-STAR grants.  Such requests must include a compelling justification.

Termination of Award:  NIH may terminate a NRSA MARC institutional academic and research training grant before its normal expiration date if it determines that the grantee has materially failed to comply with the terms and conditions of the award or to carry out the purpose for which the award was made. If an award is terminated for cause, NIH will notify the grantee organization in writing of this determination, the reasons for the determination, the effective date, and the right to appeal the decision. NIH also may terminate an award at the request of the grantee.

An organization that wants to terminate a MARC grant before the scheduled termination date must notify NIGMS immediately.  In such cases, NIH will issue a revised NGA to specify the changed period of support and to show prorated MARC trainee stipends, depending on the amount of time spent in training.

Change of Institution: NRSA MARC institutional academic and research training grants may not be transferred from one domestic organization to another except under the most unusual circumstances. Such a change generally will be approved by NIGMS only if all of the major benefits attributable to the original grant can be transferred and there is no negative impact on trainees active in the program.

Change of MARC Program Director/Principal Investigator (PD/PI): If change of a MARC PD/PI or multiple PD/PIs is necessary, support of the award is not automatic but may be continued with prior written approval by NIGMS, provided that the following conditions are met.  The current PD/PI(s) or the grantee institution must submit a written request for the change, countersigned by the appropriate institutional business official, to the MARC Branch program and grants management staff describing the reasons for the change, and include a new leadership plan (for changes in multiple PD/PIs).  The Biographical Sketch of the proposed MARC PD/PI must be provided.  The information in the request must establish that the specific aims of the original peer-reviewed MARC program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate academic and research training skills 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 MARC Program:  A rationale must be provided for any proposed changes in the original, peer-reviewed research training program objectives.  Any change requires prior approval by MARC Branch program staff.  If the new program does not satisfy this requirement, the award will be terminated. 

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, PHS Form 2590, annually and annual financial statements as required in the NIH Grants Policy Statement.  The NRSA MARC U-STAR program is not subject to SNAP.

The NRSA instructions for the Non-Competing Grant Progress Report for an institutional research training grant in, PHS Form 2590) must 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 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.  Additional information that should be included in the annual progress report in concert with the PHS Form 2590 instructions:

3.A. 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.

MARC Trainee Reporting Requirements:  The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed (first 12 month interval) and reappointment (second and final 12 month interval) to the MARC training grant.  This form must be submitted to NIGMS at or before the start of each participant’s appointment or reappointment.   If registered in the NIH eRA Commons, grantees may submit the PHS 2271 data electronically using the xTrain application. More information on xTrain is available at https://commons.era.gov/commons/.  The MARC trainee appointment or reappointment should begin on June 1, annually; the anticipated start of the MARC grant.  A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving Kirschstein-NRSA support.

If registered in the NIH eRA Commons, grantees may submit the PHS 2271 data electronically using the xTrain application. More information on X-TRAIN is available at https://commons.era.gov/commons/

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.

Publication and Sharing of Research Results:   NIH supports the practical application and sharing of outcomes of funded research.  Therefore, trainees should make the results and accomplishments of their Kirschstein-NRSA research training activities available to the research community and to the public at large.  The grantee organization should assist trainees in these activities, including the further development of discoveries and inventions for furthering research and benefiting the public.  No restrictions should be placed on the publication of results in a timely manner.

Trainees are encouraged to submit reports of their findings for publication to the journals of their choice.  For each publication that results from a trainee’s research, NIH support should be acknowledged by a footnote in language similar to the following:  “This investigation was supported by the National Institutes of Health under Ruth L. Kirschstein National Research Service Award (number).  Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.  In addition, federal funding must be acknowledged as provided in “Public Policy Requirements and Objectives-Availability of Information-Acknowledgment of Federal Funding.”

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, NRSA participants should be notified that they may be contacted after the completion of their appointment 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.

Inventions:  Traineeships made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required for institutional training grants. 

Copyrights:  Except as otherwise provided in the terms and conditions of the award, the recipient is free to arrange for copyright without approval when publications, data, or other copyrightable works are developed in the course of work under a PHS grant-supported project or activity. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes.

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.  Evaluation results should be included as part of the Final Progress Report.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Shawn R. Drew, Ph.D.
MARC Program Director
National Institute of General Medical Sciences
45 Center Drive, Room 2AS.37B, MSC 6200
Bethesda, MD  20892-6200
Telephone: (301) 594-3900
FAX:  (301) 580 2753
E-mail: DrewL@nigms.nih.gov

Or

Adolphus Toliver, Ph.D.
Chief, MARC Branch
National Institute of General Medical Sciences
45 Center Drive, Room 2AS.37H, MSC 6200
Bethesda, MD  20892-6200
Telephone: (301) 594-3900
FAX:  (301) 580 2753
E-mail: ToliverA@nigms.nih.gov

2.  Peer Review Contacts:

Helen R. Sunshine, Ph.D.
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
E-mail: SunshinH@nigms.nih.gov

3. Financial or Grants Management Contacts:

Lori Burge
Division of Extramural Activities
National Institute of General Medical Sciences
45 Center Drive, Room 2AN.50B, MSC 6200
Bethesda, MD  20892-6200
Telephone: (301) 451-3781
FAX: (301) 480-2554
E-mail: BurgeL@nigms.nih.gov

Section VIII. Other Information 


Required Federal Citations

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

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

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

Sharing Research Data: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

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

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

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.

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 SF424 (R&R)application; 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-09-116 .html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. 

NIH Public Access Policy Requirement: In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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

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

URLs in NIH Grant Applications or Appendices: All applications and proposals for NIH funding must be self-contained within specified page limitations. 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 FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of 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.

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