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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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov)

Title: Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Predoctoral Training Program in Systems Biology of Developmental Biology & Birth Defects(T32)

Announcement Type
This is a reissue of PAR-08-054.

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

Program Announcement (PA) Number: PAR-10-193

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.

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)
93.865

Key Dates
Release Date: May 11, 2010
Opening Date: June 13, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Submission Dates: June 14, 2010, April 25, 2011, April 25, 2012
Application Submission Dates: July 13, 2010, May 25, 2011, May 25, 2012
Peer Review Date: October/ November 2010, 2011, and 2012
Council Review Dates: January 2011, January 2012, January 2013
Earliest Anticipated Start Dates: April 2011, 2012 and 2013
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. 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. Research Training Objectives

The objective of this Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grant (T32) program issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is to provide research training to predoctoral students interested in establishing research careers that use systems biology approaches to study developmental biology and the formation of structural birth defects.

Purpose and Background

Embryonic development is controlled by complex interactions between numerous genes and proteins and depends upon the precise quantity and ratio of those factors over time. Additionally, the events and processes that comprise development are directed by the physiological and mechanical properties of the cells and tissues involved. Historically, individual studies of embryogenesis have involved techniques that are confined to a small number of disciplines, and have examined only a few factors and events. However, a complete understanding of the complexities of embryogenesis requires studies that use multiple disciplines to examine numerous factors and events simultaneously.

The field of Systems Biology enables a more holistic examination of living systems by studying numerous factors and events with techniques from multiple disciplines, including molecular biology, cell biology, genetics, physiology, physics, bio-mechanics, imaging, modeling, bio-informatics, and quantitative analysis of high through-put data. Individuals with expertise both in Systems Biology and in Developmental Biology will be able to perform the advanced analyses required to elucidate the complexities of normal embryonic development and of the causes of structural birth defects. One way to provide students with necessary expertise in these different fields is to create training programs that combine Systems Biology and Developmental Biology research.

Accordingly, this funding opportunity announcement (FOA) encourages applications for interdisciplinary NRSA T32s to train advanced predoctoral graduate students in Systems Biology and Developmental Biology. Proposed T32 programs should be designed to teach each student to use the approaches of Systems Biology to study Developmental Biology and/or the formation of birth defects. These programs will help ensure that the next generations of researchers will have the skills needed to significantly advance our understanding of normal developmental processes and of the processes that lead to structural birth defects. This FOA addresses the recommendations of a panel of experts who recently advised NICHD on future research priorities for Developmental Biology (see http://www.nichd.nih.gov/publications/pubs_details.cfm?from=&pubs_id=5672). Their recommendations included targeting training programs to specific research areas, such as systems biology or quantitative aspects of development.

The NRSA T32 allows the Training PD/PI to develop a curriculum of study and a research experience necessary to provide high quality research training, and to select the trainees for that program. For each appointed trainee, the grant offsets the cost of stipend, tuition, fees, travel and trainee related expenses (including health insurance) at approved NRSA support levels (see Section II, Allowable Costs).

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) T32 award mechanism. Awards may be made for periods up to 5 years and are renewable.

The Training PD/PI will be solely responsible for planning, directing, and executing the proposed research training program.

This funding opportunity announcement (FOA) uses the non-modular budget format. Follow the Instructions for preparing an NRSA institutional research training (T32) 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 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 the ICs provide 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 research training not otherwise available and must be expended in conformance with OMB Cost Principles, the NIH Grants Policy Statement, and the NRSA regulations, policies, guidelines, and conditions set forth in this document.

2.A. Allowable Costs

Stipends: Stipends are provided as a subsistence allowance for trainees to help defray living expenses during the research training experience and are based on a 12-month appointment period. The stipend is not provided as a condition of employment with either the Federal Government or the grantee institution nor is it to be considered a payment for services performed. Stipends will be based on the annual NIH stipend levels at the time of award. Stipends may be adjusted only at the time of appointment or reappointment and may not be changed in the middle of an appointment period. For appointments of less than a full year, the stipend will be based on a monthly or daily pro-ration of the annual amount. No departure from the established stipend schedule may be negotiated by the institution with the trainee. For the most recent stipend levels see the Ruth L. Kirschstein National Research Service Award (NRSA) website.

Tuition and Fees: Applicants should request full needs for tuition and fees. The NIH IC 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 predoctoral trainee. If the program supports formally combined dual-degree training (e.g., M.D.-Ph.D., D.D.S.-Ph.D.), the amount provided per trainee will be 60% of the level requested up to $21,000 per year. For a full description of the NIH tuition policy, see NOT-OD-06-093.

Trainee Travel: Trainee travel to attend scientific meetings and workshops that the institution determines to be necessary for the individual s research training experience is an allowable trainee expense. Funds may not be expended to cover the costs of travel between the trainee’s place of residence and the training institution, except that the grantee organization may authorize a one-way travel allowance in an individual case of extreme hardship. Amounts for trainee travel are not uniform throughout the NIH. Trainees must be appointed to this training program at the time of actual travel for this to be an allowable cost. Applicants are strongly urged to contact appropriate IC scientific staff listed under Section VII for guidance prior to preparing the application.

Additionally, support for travel to a research training experience away from the institution may be permitted. Research training experiences away from the parent organization must be justified considering the type of opportunities available for training, and how the opportunities differ from and complement those offered at the parent institution, and the relationship of the proposed training experience to the trainee’s career stage and goals. This type of travel and research training requires prior approval from the NIH awarding component, and, if not known at the time of application, may be submitted at any time during the award period.

Training Related Expenses, including Health Insurance (TRE): The applicant institution may request the NIH standard NRSA Training Related Expenses (FY 2009: $4,200 annually for each predoctoral trainee) to help defray other research training expenses, such as health insurance (self-only or family, as applicable), staff salaries, consultant costs, equipment, research supplies, and faculty/staff travel directly related to the research training program. Health insurance is 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 (see NOT-OD-06-093 for additional information). Funds are provided as a lump sum on the basis of the predetermined amount per predoctoral trainee approved for support.

Under exceptional circumstances, which can include accommodating the disabilities of a trainee, it is possible to request training related expenses above the standard level. 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).

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. 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 NRSA training program.

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 teaching 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 Training PD/PI must approve all instances of employment on research grants to verify that the circumstances will not detract from or prolong the approved 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:

Foreign institutions are not eligible to apply. The applicant institution must have a strong research program in systems biology and in developmental biology and/or birth defects research. It must also have the requisite staff and facilities on site to conduct the proposed research training program.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to organize and implement a high-quality research training program is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

The Training PD/PI should be an established basic, behavioral, and/or clinical researcher with the skills, knowledge, a successful past training record, and available resources to conduct the proposed research training program at the sponsoring institution. The Training PD/PI will be responsible for the selection and appointment of eligible trainees to the NRSA training grant, for the overall direction, management and administration of the research training program, program evaluation, and the submission of all required forms in a timely manner.

2. Cost Sharing or Matching

Cost sharing is not required.

3. Other-Special Eligibility Criteria

Training Program: Trainees appointed to the research training program must have the opportunity to carry out supervised biomedical, behavioral, or clinical research with the primary objective of developing or enhancing their research skills and knowledge in preparation for a health-related research career. Trainees must commit full-time effort, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies, to the program and its related research activities, consonant with NRSA guidelines. Within the full-time training period, research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience.

A Kirschstein-NRSA institutional research training grant must be used to support a program of full-time research training. It may not be used to support studies leading to the M.D., D.D.S., or other clinical, health-professional training except when those studies are part of a formal combined research degree program, such as the M.D./Ph.D.

Trainee Appointments: All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the NIH awarding unit, or when trainees are appointed to approved, short-term training positions.

No individual trainee may receive more than 5 years of aggregate NRSA support at the predoctoral level, including any combination of support from institutional training and individual fellowship awards. Any exception to the maximum period of support requires a waiver from the NIH awarding component based on a review of the written justification from the individual trainee, and endorsed by the Training PD/PI and the sponsoring grantee institution. Trainees seeking additional support are strongly advised to consult with the NIH awarding office.

Trainees must be advanced graduate students in a program leading to a Ph.D. in science or equivalent research doctoral degree program. They must have the opportunity to carry out supervised research in systems biology of developmental biology/birth defects with the primary objective of developing their research skills and knowledge of these areas of research. Health-professional students and graduate students in the quantitative sciences who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs are also eligible. Trainees must be able to commit full-time effort, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies, to the program and its related research activities, consonant with NRSA guidelines.

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.

Predoctoral Trainees: Predoctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA appointment, must be training at the post-baccalaureate level, and be enrolled in a program leading to a Ph.D. in science or in an equivalent research doctoral degree program. Health-professional students, graduate students in the quantitative sciences, or individuals in postgraduate clinical training who wish to interrupt their studies for a year or more to engage in full-time research training before competing their formal training programs are also eligible.

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 Training 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

2) Organizational/Institutional Registration in the eRA Commons

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

Both the PD/PI 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.

For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

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 Training 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
PHS 398 Cover Page Supplement
PHS398 Checklist

Optional Components:
PHS398 Cover Letter
Training Subaward Budget Attachment(s) Form (when applicable)

Special Program Requirements

A. Trainee Appointments

Trainees are customarily appointed for full-time, 12-month continuous periods. No trainee may be appointed for less than nine months during the initial period of appointment except with prior approval of NICHD program staff. All trainees are required to pursue their research training on a full-time basis, at a minimum of 40 hours per week, or as specified by the sponsoring institution in accord with its own policies. The amount of the stipend and tuition (defined for the purposes of NRSA as the cumulative amount of tuition and fees) for each full appointment period must be obligated from funds available at the time the individual begins training. See http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html for additional details on allowable tuition and fees.

By law, an individual trainee may receive no more than five years of NRSA support in the aggregate at the predoctoral level, including any combination of support from institutional training grants and individual fellowship awards.

B. Recruitment

The NRSA T32 program is committed to excellence in research training and to filling the projected need for future investigators in particular areas of research. In order to achieve these goals, T32s should appoint only those individuals who are committed to careers in research. T32s should teach their trainees how to apply for subsequent support through individual fellowships, mentored career development awards, or independent research project grants. Additionally, T32s must propose plans to recruit and retain trainees from a broad representation of the American people, including individuals with disabilities, individuals from disadvantaged backgrounds and individuals from racial or ethnic groups underrepresented in the biomedical sciences (see Supplemental Application Instructions , 6, below).

C. Evaluation

The Training PD/PI must develop methods for ongoing evaluation of the quality of the training program. Although the T32 application process requires extensive career tracking information, it is often useful to obtain more proximal feedback from trainees. For example, Training PD/PIs are encouraged to develop plans to obtain feedback from current and former trainees to help identify weaknesses in the training program and to provide suggestions for program improvements.

3. Submission Dates and Times

See Section IV.3A for details.

3.A. Submission, Review and Anticipated Start Dates
Opening Date: June 13, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Submission Dates: June 14, 2010, April 25, 2011, April 25, 2012
Application Submission Dates: July 13, 2010, May 25, 2011, May 25, 2012
Peer Review Date: October/ November 2010, 2011, and 2012
Council Review Dates: January 2011, January 2012, January 2013
Earliest Anticipated Start Dates: April 2011, 2012 and 2013

3.A.1. Letter of Intent

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

Descriptive title of proposed training program
Name, address, and telephone number of the Principal Investigator
Names of other key personnel
Participating institutions
Number and title of this funding opportunity
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains will allow NICHD staff to estimate the review workload and plan the review.

The letter of intent may be e-mailed to:

James N. Coulombe, Ph.D.
Program Director, Developmental Genetics and Immunology
Developmental Biology, Genetics and Teratology Branch
Center for Developmental Biology and Pediatric Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development
RM 4B01, MSC 7510
6100 Executive Blvd
Bethesda, MD 20892-7510
(Rockville, MD 20852 for courier or express service)
Telephone: 301 451-1390
FAX: 301 480-0303
Email: [email protected]

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 Training 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 Commons. The 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 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. Nondegree 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.

Service Payback: Not applicable to NRSA Predoctoral training.

6. Other Submission Requirements

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

The NIH requires the Training PD/PI 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 IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

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

This policy applies to all investigator-initiated new (type 1), 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 T32 applications:

Background

Provide rationale for the proposed research training program, relevant background history, and the need for the research training proposed. Indicate how the proposed program relates to current training activities at the applicant institution. See SF424, Section 8.7. Research Training Program Plan Components, Item 2, Background.

Program Plan

a. Program Administration Training Program Director/Principal Investigator (PD/PI): The Training PD/PI must possess the scientific background and leadership and administrative capabilities required to coordinate, supervise, and direct the proposed research training program. The Training PD/PI will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The Training PD/PI must provide potential trainees information associated with NRSA programs and submit all required trainee forms in a timely manner. See SF424, Section 8.7. Research Training Program Plan Components, Item 3, Program Plan.

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, including successful competition for research support in the area of the proposed research training program. This section should also describe the past research training record of the program faculty, including the success of former trainees of the designated preceptors/mentors in establishing productive scientific careers. Evidence can include successful completion of programs and further career advancement of former trainees such as receipt of fellowships, career awards, further training appointments and similar accomplishments. Evidence of a productive scientific career can include a record of successful competition for research grants, receipt of special honors or awards, a record of publications, receipt of patents, promotion to scientific positions, and any other accepted measures of success. See SF424, Section 8.7. Research Training Program Plan Components, Item 3, Program Plan.

c. Proposed Training: The program should plan to provide didactic training as well as laboratory or clinical research experience. This should include a plan for determining trainee experience and needs and monitoring progress to accomplish desired goals. The program should develop trainee skills in understanding research, applying their critical abilities to conduct research, identifying problems in the process of conducting research, raising questions and proposing solutions to resolving problems. Trainees should be prepared to utilize their research findings as they pursue future research. Programs should provide all NRSA trainees with additional professional development skills and career guidance including instruction and training in grant writing in order to apply successfully for future career development and independent research support. See SF424, Section 8.7. Research Training Program Plan Components, Item 3, Program Plan.

d. Training Program Evaluation: The application must describe an evaluation plan to review and determine the quality and effectiveness of the training program. This should include plans to obtain feedback from current and former trainees to help identify weaknesses in the training program and to provide suggestions for program improvements, as well as plans for assessing trainees career development and progression, including degree completion, publications, and post-training positions. Evaluation results should be included in future competing continuation (renewal) applications and as part of the Final Progress Report. See SF424, Section 8.7. Research Training Program Plan Components, Item 3, Program Plan.

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. This section should include information about trainee admissions and completion records, qualifications of applicants, and current trainee qualifications. See SF424, Section 8.7. Research Training Program Plan Components, Item 3, Program Plan.

f. Institutional Environment, Commitment, and Resources: The administration of the applicant institution as well as all participating units and departments should include information in the application that documents institutional support and commitment to the goals of the research training program. The application should include a description of support (financial and otherwise) to be provided to the proposed program. This could include, for example, space, shared laboratory facilities and equipment, funds for curriculum development, release time for the Training PD/PI and/or participating faculty, support for additional trainees in the program, or any other creative ways to improve the climate for the establishment and growth of the research training program. Note: See SF424, Section 8.7. Research Training Program Plan Components, Item 3, Program Plan.

Recruitment and Retention Plan to Enhance Diversity

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/nsf07308/content.cfm?pub_id=3633&id=3) In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at HHS - Poverty Guidelines, Research, and Measurement. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

Recruitment and retention plans related to a disadvantaged background (C1 and C2) are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement. Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background. Such decisions will be made on a case-by-case basis, based on appropriate documentation.

Competing continuation and non-competing applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:

For those trainees who were enrolled in the training program, the report should include information about the duration of research training and whether those trainees finished their training in good standing.

This Program Announcement requires all applicants to submit a recruitment and retention plan to enhance diversity (see SF424, Section 8.7. Research Training Program Plan Components, Item 4, Recruitment and Retention to Enhance Diversity). Additional information on the required Recruitment and Retention Plan to Enhance Diversity is available at Frequently Asked Questions Recruitment and Retention Plan to Enhance Diversity (Diversity FAQs).

Applications without a diversity recruitment and retention plan will be considered incomplete and will not be reviewed.

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. See SF424, Section 8.7. Research Training Program Plan Components, Item 5, Plan for Instruction in the Responsible Conduct of Research.

Applications without a plan for training in the responsible conduct of research will be considered incomplete and will not be reviewed.

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 should include the data requested in the SF424 using the instructions for submission of Data Tables 1-12 (See Data Table Instructions). The information in the data tables will be used by reviewers during peer review and NIH staff in reaching funding decisions.

NOTE: It is no longer required for applicants to provide pre-enrollment data for individuals with disabilities or individuals from disadvantaged backgrounds on Data Tables 7A and 7B (see: NOT-OD-09-135).

NOTE: Renewal applications: Reporting of information on completion rate and time to degree for graduate students in doctoral degree programs that have been supported by NIH training awards must be documented in the Program Statistics section of Table 12A (see NOT-OD-09-141). Information must include:

Note: See SF424, Section 8.7. Research Training Program Plan Components, Item 13, Data Tables.

6.D. Appendix Materials

Do not use the appendix to circumvent the page limitations of the Training Plan. The specifically required Data Tables 1-12 described in the SF424 are exempted from the application page limits. Check with the appropriate PHS awarding component contacts listed in the FOA for the types of appendix materials that are allowed and typically included or are not allowed in applications reviewed for that specific awarding component.

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

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

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 research training program to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scores 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.

Although individual Institutes and Centers may have specialized review criteria appropriate for their special initiatives and mission, most research training applications are evaluated using the following criteria:

Training Program and Environment:

Training Program Director/Principal Investigator (Training PD/PI):

Preceptors/Mentors:

Trainees:

Training Record:

For renewal applications:

For applications that request short-term research training positions:

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

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

Recruitment and Retention Plan to Enhance Diversity: Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from all three underrepresented groups (A, B, and C). For renewal applications, peer reviewers will evaluate whether the experience in recruitment during the previous award period has been incorporated into the formulation of the plan for the next award period. The review panel’s evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NIH awarding component, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

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.

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 Training PD/PI may submit a written request to the awarding component to change a trainee appointment to less than full-time. Such requests will be considered on a case-by-case basis and must be approved by the awarding Institute in advance for each budget period. The nature of the circumstances requiring part-time training might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission for part-time training will not be approved to accommodate other sources of funding, job opportunities, clinical practice, clinical training, or for other responsibilities associated with the trainee’s position at the institution. In each case, the Training 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.

Carryover of Unobligated Balances: Most of the NIH funding components require prior written approval for carryover of funds from one budget period to the next. When required, such requests must include compelling justification including the status of trainee appointments to the program. If not stated on the Notice of Award, the Training PD/PI should contact the applicable IC’s Grants Management contact to determine the funding IC’s carryover policy.

Termination of Award: NIH may terminate a Kirschstein-NRSA institutional 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 training grant before the scheduled termination date must notify the NIH awarding office immediately. In such cases, NIH will issue a revised NGA to specify the changed period of support and to show prorated trainee stipends, depending on the amount of time spent in training.

Change of Institution: Kirschstein-NRSA institutional 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 the NIH awarding office 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 Training Program Director/Principal Investigator (Training PD/PI): If change of a Training PD/PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NIH funding component, provided that the following conditions are met. The current Training PD/PI or the grantee institution has submitted a written request for the change, countersigned by the appropriate institutional business official, to program and grants management staff at the NIH funding component describing the reasons for the change. The Biographical Sketch of the proposed Training PD/PI, including a complete listing of active research grant support, must be provided. The information in the request must establish that the specific aims of the original peer-reviewed program will remain unchanged under the direction of the new Training PD/PI and that the new Training PD/PI has the appropriate research training and administrative expertise to lead the training program. This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.

Change of Program: A rationale must be provided for any proposed changes in the original, peer-reviewed research training program objectives. Any change requires prior approval by program staff of the NIH funding component. If the new program does not satisfy this requirement, the award will be terminated.

Service Payback Provisions: Not applicable to NRSA Predoctoral training.

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 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.

Trainee Reporting Requirements: The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant. This form must be submitted to the awarding IC at or before the start of each participant’s appointment or reappointment. Grantees will be required to submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at https://commons.era.gov/commons/. An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year. No funds may be provided until such documents are submitted. 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.

Within 30 days of the end of the total support period for each participant, the institution must submit a Termination

Notice (PHS Form 416-7) to the NIH. Grantees will be required to submit the PHS 416-7 data electronically using the xTrain system. More information on xTrain 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.

Graduate Student Reporting: For renewal applications, the grantee institution must report the following information for graduate students in doctoral degree programs that have been supported by NIH training awards:

Information on completion rates and time to degree should be reported in the Program Statistics section of Table 12A (Predoctoral Trainees Supported by this Training Grant) when submitting a renewal application (SF424) or a non-competing continuation progress report (PHS 2590).

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:

James N. Coulombe, Ph.D.
Program Director, Developmental Genetics and Immunology
Developmental Biology, Genetics and Teratology Branch
Center for Developmental Biology and Pediatric Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development
RM 4B01, MSC 7510
6100 Executive Blvd
Bethesda, MD 20892-7510
(Rockville, MD 20852 for courier or express service)
Telephone: 301 451-1390
FAX: 301 480-0303
Email: [email protected]

2. Peer Review Contacts:

Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
(Rockville, MD 20852 for courier or express service)
Telephone: 301 496-1485
FAX: 301 402-4104

3. Financial or Grants Management Contacts:

Bryan Clark, MBA
Chief Grants Management Officer
Grants Management Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Blvd., 8A01A MSC 7510
Bethesda, MD 20892-7510
(Rockville, MD 20852 for courier or express service)
Telephone: (301) 435-6975
FAX: (301) 402-0915
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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

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

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

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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