Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)

Title: Limited Competition for the MENTOR Award: Phase II (T32)

Announcement Type
This is a re-issue of a previous Letter of Invitation for a Limited Competition.

Request For Applications (RFA) Number: RFA-HD-06-103

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: July 5, 2006
Letters of Intent Receipt Date(s): July 29, 2006
Application Receipt Date(s): August 29, 2006
Peer Review Date(s): November 2006
Council Review Date(s): January 2007
Earliest Anticipated Start Date(s): May 01, 2008
Additional Information to Be Available Date (Url Activation Date): July 15, 2006
Expiration Date: August 30, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

• This is an announcement of a limited competition to solicit competing continuation grant applications from the Principal Investigators who were awarded NICHD MENTOR awards in 2003 (http://www.nichd.nih.gov/funding/mech_training.htm).
• This RFA for Limited Competition will provide support for up to five years to continue the existing training program(s).
• Approximately $1.5 million dollars is expected to be awarded each year for five years beginning with FY 2007.
• Up to three awards will be issued.
• The award mechanism is the National Research Service Award (NRSA) Institutional Training Grant (T32).
• The only eligible organizations are those that were awarded NICHD MENTOR awards in 2003.
• The eligible Principal Investigators are the current Principal Investigators of those awards or a new Principal Investigator who has replaced that person.
• See Section IV.1 for application materials.
• Telecommunications for the hearing impaired is available at: TTY 301-451-5936.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

This Limited Competition RFA invites recipients of the NICHD MENTOR Award for Excellence in Research Training who are currently in the first phase of their MENTOR Award to apply for the second phase.

Background

The NICHD MENTOR Award for Excellence in Research Training consists of two competitive phases of up to five years each (http://www.nichd.nih.gov/funding/mech_training.htm). Recipients of the first phase are eligible to apply for the second phase using an abbreviated application format that will undergo expedited peer review. This RFA invites the T32 grantees who currently are in the first phase of their MENTOR Award to apply for the second phase. To be considered for a MENTOR Award, a T32 training program must have been funded continuously by NICHD for at least 10 years; it must receive an outstanding score on its competing continuation application; and it must have a history of providing a successful training environment. In addition, the training program must have demonstrated superior attention to its trainees' and/or the community's needs. Examples of superior attention include particularly effective courses, mentoring, training strategies, and trainee-faculty interactions; superior strategies for providing cross-discipline training, or training in both basic and clinically oriented research; superior training in health issues that disproportionately affect minority populations; and superior recruitment and retention of underrepresented minority trainees.

Scope

The continuation of the MENTOR Award is dependent upon demonstration of continued excellence of the training program, including consistent overall design and goals; the same or equivalent program director and training faculty; demonstration of continued training success; and a consistent or improving applicant population. In addition, the program must demonstrate continued and improving attention to the needs of its trainees and to the needs of the community.

The second phase may last for up to five years. During the last year of the MENTOR Award, grantees may submit a normal competing application to continue their training program as a standard T32.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH National Research Service Award (NRSA) Institutional Training Grant (T32) award mechanism.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed research training program.

This funding opportunity uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application, following the Instructions for preparing an NRSA application

2. Funds Available

Applicants may request up to the number of training slots that were approved in the previous competing continuation application summary statement and a project period of up to five years. Although the financial plans of the NICHD provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

Grantees are expected to be familiar with and comply with applicable costs policies and the NRSA Guidelines (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm). Funds may be used only for those expenses that are directly related and necessary to the research training not otherwise available and must be expended in conformance with OMB Cost Principles, the NIH Grants Policy Statement (rev. 12/01/03), and the NRSA regulations, policies, guidelines, and conditions set forth in this document.

Allowable Costs:

A. 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. The fiscal year (FY) 2006 annual stipend level for a predoctoral trainee is $20,772. For postdoctoral trainees, the annual stipend is based on the number of full years of prior relevant postdoctoral experience at the time of the trainee’s appointment. The FY 2006 range of annual postdoctoral stipend levels is $36,996 to $51,036. 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. (see http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-06-026.html for specific information).

B. Tuition, Fees, and Health Insurance

The NIH will offset the combined costs of tuition, fees and health insurance (either self-only or family as appropriate) at the rate in place at the time of the award. The rate currently provides 100% of all costs up to $3,000 and 60% of costs in excess of $3,000 per trainee. Costs associated with this category are allowable only if they are required for specific courses as part of the approved research training program and are applied consistently to all persons in a similar research training status at the institution regardless of the source of support. Tuition at the postdoctoral level is limited to that required for specific courses in support of the approved training program which should be identified in the application. A full description of the NIH tuition policy is in the NIH Grants Policy Statement and on the NIH website at: http://grants.nih.gov/training/nrsaguidelines/nrsa_toc.htm.

C. Trainee Travel

Trainee travel to attend scientific meetings and workshops that the institution determines to be necessary for the individual’s research training experience is an allowable 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.

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.

D. Trainee Related Expenses (TRE)

The applicant institution may request the NIH standard NRSA Training Related Expenses (FY 2006, $2,200 annually for each predoctoral trainee and $3,850 annually for each postdoctoral trainee) to help defray other research training expenses, such as staff salaries, consultant costs, equipment, research supplies, and faculty/staff travel directly related to the research training program (see

http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-06-026.html for additional information). Funds are provided as a lump sum on the basis of the predetermined amount per predoctoral and postdoctoral 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.

When short-term training is included in the research training program, the applicant institution may request the proportion of the NIH standard annual NRSA Training Related Expenses to help defray other costs of the short-term training experience. Since some NIH ICs do not support short-term research training positions under the T32 or support them on a limited basis only, applicants are urged to contact the appropriate NIH IC before requesting short-term research training positions as part of a T32 application.

E. Facilities and Administrative Allowance

A facilities and administrative allowance based on 8% of modified total direct costs (exclusive of tuition and fees, health insurance, and expenditures for equipment) may be requested.

F. 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.

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. Training Program Directors 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: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm

Educational Loans or G.I. Bill: An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation. Postdoctoral trainees in their first and third years of training may also be eligible to participate in the NIH Extramural Loan Repayment Program. Information about this program is available at: http://www.lrp.nih.gov/.

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

Only institutions that received a MENTOR award in 2003 and that have remained substantially unaltered since their last review are eligible to apply for continuation of these awards.

1.B. Eligible Individuals

Individuals eligible to apply for the second phase of the MENTOR award are the principal investigators (program directors) to whom the MENTOR was awarded or a new principal investigator (program director) who has replaced that person. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

2. Cost Sharing or Matching

Not applicable

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 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. 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 Mentor 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. Similarly, trainees may not accept NRSA support for clinical training that is part of residency training leading to clinical certification in a medical or dental specialty or subspecialty. It is permissible and encouraged, however, for clinicians to engage in NRSA supported full-time postdoctoral research training even when that experience is creditable toward certification by a clinical specialty or subspecialty board.

Trainee Citizenship

At the time of appointment to the training program, individuals selected for research training supported by NRSA institutional training grants must be citizens or non-citizen nationals of the United States, or must have been lawfully admitted to the United States for permanent residence, i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or some other legal verification of legal admission as a permanent resident. Non-citizen nationals are generally persons born in outlying possessions of the United States (e.g., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible for NRSA support. In addition, trainees must be able to commit full-time effort in the program at the time of appointment.

Predoctoral Trainees

Predoctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA appointment, must be training at the postbaccalaureate 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.

Postdoctoral Trainees

Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following: D.M.D., D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.Sc., Pharm.D., N.D. (Doctor of Naturopathy), D.S.W., Psy.D, as well as a doctoral degree in nursing research or practice. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is acceptable. Research training at the postdoctoral level must emphasize specialized training to meet national research priorities in the biomedical, behavioral, or clinical sciences that are within the scientific purview of the NIH awarding components participating in this research training program.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number (HD-06-103) of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): July 29, 2006
Application Receipt Date(s): August 29, 2006
Peer Review Date(s): November 2006
Council Review Date(s): January 2007
Earliest Anticipated Start Date: May 01, 2008

3.A.1. Letter of Intent

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

• Descriptive title of proposed research
• Name, address, and telephone number of the 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 allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Steven Klein, Ph.D.
National Institute of Child Health and Human Development
6100 Executive Boulevard, 4B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 496-5541
Email: kleins@mail.nih.gov

3.B. Sending an Application to the NIH

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

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

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

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NICHD. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are not allowable charges for either stipends or tuition on institutional training grants since stipends and tuition costs may not be charged to the grant before the trainee appointment is actually made. However, the policies governing the pre-award cost authority for the expenditure of the other funds provided in a training grant are those permitted in the NIH Grants Policy Statement as follows:

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

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

The National Research Service Award (NRSA) policies apply to this program. Awards are contingent upon availability of funds. Furthermore, the duration of the award and the number of funded training positions may be less than the levels recommended by the peer review group, based on programmatic and budgetary considerations.

Funds for continuation support beyond the initial year are determined by the success as described in the annual progress report, the timely submission of required forms, and the availability of funds for continuation programs.

Concurrent awards: An NRSA appointment may not be held concurrently with another federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.

Taxability of Stipends: Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-154, impacts on the tax liability of all individuals supported under the NRSA program. Under that section, non-degree candidates are now required to report as gross income all stipends and any monies paid on their behalf for course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization.

The IRS and Treasury Department released regulations in January 2005 (Revenue Procedure 2005-11) clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed by a school, college, or university where the student is pursuing a course of study. Our understanding is that these final regulations do not apply to or impact NRSA programs or awards. An NRSA stipend is provided by the NIH as a subsistence allowance for NRSA fellows and trainees to help defray living expenses during the research training experience. NRSA recipients are not considered employees of the Federal government or the grantee institution for purposes of the award. We must note that NIH takes no position on the status of a particular taxpayer, nor does it have the authority to dispense tax advice. The interpretation and implementation of the tax laws are the domain of the IRS.

Individuals should consult their local IRS office about the applicability of the tax laws to their situation and for information on their tax obligations.

Service Payback: As specified in the NIH Revitalization Act of 1993, NRSA recipients incur a service payback obligation for the first 12 months of postdoctoral support. Additionally, the Act specifies that the second year of postdoctoral NRSA training support will serve to pay back a postdoctoral service payback obligation. (See Section VI.2.Administrative and National Policy Requirements for further details.)

6. Other Submission Requirements

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/sbe/srs/women/start.htm) 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 http://aspe.hhs.gov/poverty/indix.shtml. 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 are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.

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:

• Students or postdoctorates who applied for admission or positions within the department(s)/programs(s) relative to the training grant,
• Students or postdoctorates who were offered admission to or a position within the department(s)/program(s),
• Students actually enrolled in the academic program relevant to the training grant,
• Students or postdoctorates who were appointed to the research training grant.

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

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel’s evaluation will be included in an administrative note in the summary statement. If the recruitment and retention plan to enhance diversity 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 as needed, will determine whether amended plans and reports submitted after the initial review are acceptable.

This Program Announcement requires all applicants to submit a recruitment and retention plan to enhance diversity. If an application is received without a plan, the application will be considered incomplete and will not be reviewed.

Training in the Responsible Conduct of Research: Every NRSA trainee supported by an institutional research training grant must receive instruction in the responsible conduct of research. For more information on this provision, see the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992, see http://grants1.nih.gov/grants/guide/notice-files/not92-236.html. Applications must include a description of a program to provide formal or informal instruction in scientific integrity and ethical principles in research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will not be reviewed.

• Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Within the context of training in scientific integrity, it is also beneficial to discuss the relationship and the specific responsibilities of the institution and the graduate students or postdoctorates appointed to the program.
• Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, trainee attendance, and the frequency of instruction.
• The rationale for the proposed plan of instruction must be provided.
• Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in future competing continuation and non-competing applications. The NIH encourages institutions to provide instruction in the responsible conduct of research to all graduate students, postdoctorates, and research staff regardless of their source of support.

The MENTOR competing continuation application consists of three parts:

I. Seven form pages from the NRSA application, available at: http://grants.nih.gov/grants/funding/phs398/phs.398.html;

II. A narrative description of the program progress and plans, not to exceed five pages in length; and

III. Five tables, available at http://www.nichd.nih.gov/LOI/HD-06-103/mentortableexamples.htm

These instructions should be followed in completing your application; only the information listed below is required for the application:

I. Submit the following seven Form Pages from the PHS 398 application package:

1. Form Page 1 - Face Page

Follow the PHS 398 face page instructions.

Remember to enter HD-06-103, NICHD MENTOR Renewal for item 2.

2. Form Page 2 - Description, Performance Sites, and Key Personnel

a. Description

Summarize the essence and major features of the program. Include research areas and disciplines, levels of training, numbers and background experience of trainees, anticipated duration of training, and primary facilities. Highlight any changes, enhancements, and challenges to your program since the last competitive renewal.

b. Performance Site(s)

Follow the PHS 398 face page instructions.

c. Key Personnel

List all primary and secondary mentors presently associated with the training program. Mark with an asterisk any faculty that have joined the training program since the last competitive renewal and bracket any faculty that left the program since the last competitive renewal.

3. NRSA Substitute Form Page 3 - Table of Contents

4. NRSA Substitute Form Page 4 - Detailed Budget for Initial Budget Period

You may request up to the number of training slots that were approved in the previous competing continuation application summary statement. If the application is approved for continued support, constraints on NICHD resources may limit the number of slots awarded to the level currently funded by the MENTOR award. Indicate the level of each requested postdoctoral slot. Request the amount of stipend listed in the current NIH stipend schedule (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-032.html). Request the amount needed for fees and tuition based on the actual institutional amounts. Request the applicable NRSA amount for training related expenses. NICHD will adjust these amounts to the amounts allowed under the NRSA guidelines that are in effect at the time of award. You may also request up to $1,000 per trainee for travel.

5. Biographical Sketch Format Page

Provide up-to-date biosketches for the Program Director and all primary and secondary mentors associated with the training program. Indicate any faculty added since the last competing continuation and any faculty that left the program since the last competitive renewal. Include a biosketch for any faculty who have left since the last competing continuation. For the new faculty, the biosketch should briefly summarize experience with training students. Limit biosketches to two pages each. (NOTE: If you are requesting a change to a new program director with this renewal, please include biosketches of both the current and proposed program directors.)

6. Resources Format Page

Highlight any changes, either positive or negative, in the facilities or resources available to the training program that have occurred since the last competing continuation application.

7. Check List Form Page

II. PROGRESS REPORT/PROGRAM NARRATIVE: Not to exceed five pages, plus required tables.

1. Training Program

Provide a brief overview of the training program, highlighting any modifications, changes in focus, and new challenges since the last competing continuation. Describe how the program is meeting the trainees needs for coursework, lab work, written and oral communication and other career skills, and how the program is meeting the needs of the broader scientific community. Provide evidence that the program has continued to be highly successful during the current funding period and present plans that will ensure its continued success in the future. Justify the continuation of the MENTOR award, addressing the special features of your training program that qualify it for the MENTOR award (see the Background section of this letter for the MENTOR criteria).

2. Program Faculty and Other Key Personnel

Briefly discuss the appropriateness of the faculty to meet the goals of the training program. Highlight changes in key roles of faculty and faculty turnover, and describe the adequacy of overall faculty research support to assure trainee opportunities in the laboratory or department.

3. Trainees

Provide an overview of the recruitment, selection, retention, and formal mentoring and oversight of trainee progress, with special attention to recruitment of individuals from under-represented minority groups. Provide an update of required coursework and other milestones, with reference to instruction in the responsible conduct of science.

III. REQUIRED TABLES

Sample tables are provided (http://www.nichd.nih.gov/LOI/HD-06-103/mentortableexamples.htm). Fillable blank tables are also provided should you care to use them.

TABLE 1: Training Grant Faculty Current Funding

Provide an updated table of the training faculty, indicating primary departmental affiliation, role in the training program (director, primary mentor, associate faculty or secondary mentor), and active and pending research support (include all Federal, non-Federal, and institutional grant and contract support; if none, state "None"). List source of support, grant number, title, dates of the entire project period, and annual direct costs. Clearly identify pending grants.

TABLE 2: Candidate Pool for the Training Program

NOTE WELL: Tables 2A and 2B request information about the candidate pool from which the T32 trainees are selected and is NOT limited to those awarded T32 slots.

Table 2A - For T32 programs that train pre-doctoral candidates:

Starting with the budget year that began May 2001 and continuing through all subsequent years, give the number of ALL pre-doctoral applicants to the departments that participate in the T32 program, and state the number of those applicants who were eligible for a T32 slot (i.e., U. S. citizens or those admitted for permanent residence); the number of applicants accepted to the training program as a whole, and of those accepted, how many were eligible for a T32 slot; the number enrolled in the training program as a whole, and of those enrolled, how many were eligible for a T32 slot; the number still in the program; and degree earned, if applicable, for those no longer in the training program. In parentheses in each column, also state the number of under-represented minorities who were eligible for a T32 slot. Give the average GRE score and average undergraduate GPA for those enrolled. If your T32 program trains ONLY pre-doctoral fellows, submit only Table 2A and not Table 2B.

Example: This example will follow the data entered in the sample Table 2A.

In 1999, eight candidates applied for admission to the Department of Biochemistry for the graduate training program. Of those eight, five were U.S. citizens or permanent residents of the U.S. and, thus, were eligible for a T32 slot. Of those five eligible for a T32 slot, one was an under-represented minority. The data for the second column are entered as 8/5 (1). Of the eight candidates who applied for admission, six were accepted for admission. Of those six, four were U.S. citizens or permanent residents of the U.S. and, thus, were eligible for a T32 slot. Of those four, one was an under-represented minority. The data for the third column are entered as 6/4 (1). Of the six candidates who were offered admission, four enrolled and two of those enrolling were U.S. citizens or permanent residents of the U.S. and, thus, were eligible for a T32 slot. Of those two, one was an under-represented minority. The data for the fourth column are entered as 4/2 (1). The four students who enrolled in the program had average GREs of 2020 and an average undergraduate GPA of 3.27; these data go in the fifth and sixth columns respectively. The remaining columns ask the fate of the four students who enrolled in the Department of Biochemistry graduate program in 1999 and the data from columns 7-10 must add up to the number of candidates enrolled, given in column four. In our example, two of the four candidates who enrolled in the training program are still in the training program, and neither of them is an under-represented minority. The data for the seventh column are entered as 2 (0). This leaves two students no longer in the program. One earned a Ph.D. and graduated, and this individual was an under-represented minority. The data for the eighth column are entered as 1 (1). The ninth column is not applicable and is filled in with a zero. The final person left the training program for personal reasons before earning a degree. This person was not an under-represented minority. The data for the tenth column is recorded as 1 (0).

Again, please note that these data are not limited to those awarded a T32 slot; instead, this table is used to evaluate the pre-doctoral training program as a whole.

Table 2B - For T32 programs that train post-doctoral fellows:

Starting with the budget year that began May 2001 and continuing through all subsequent years, give the number of ALL post-doctoral applicants to the trainers who participate in the T32 program, and state the number of those applicants who were eligible for a T32 slot (i.e., U. S. citizens or those admitted for permanent residence); the number of applicants accepted and, of those accepted, how many were eligible for a T32 slot; the number that became post-docs and, of those post-docs, how many were eligible for a T32 slot; and the number still there. Of those post-docs, give the number who had previously earned Ph.D. only, M.D./Ph.D., and M.D. only, and state the number of under-represented minorities within each category. In parentheses in each column, also state the number of under-represented minorities who were eligible for a T32 slot. If your T32 program trains ONLY post-doctoral fellows, submit only Table 2B and not Table 2A.

Example: This example will follow the data entered in the sample Table 2B.

In 1999, eight candidates applied for post-doctoral positions with Dr. Jones. Of those eight, five were U.S. citizens or permanent residents of the U.S. and, thus, were eligible for a T32 slot. Of those five eligible for a T32 slot, one was an under-represented minority. The data for the second column are entered as 8/5 (1). Of the eight candidates who applied for a post-doctoral position, six were offered a position. Of those six, four were U.S. citizens or permanent residents of the U.S. and, thus, were eligible for a T32 slot. Of those four, one was an under-represented minority. The data for the third column are entered as 6/4 (1). Of the six candidates who were offered a position, four took the position and two of those were U.S. citizens or permanent residents of the U.S. and, thus, were eligible for a T32 slot. Of those two post-docs, one was an under-represented minority. The data for the fourth column are entered as 4/2 (1). Of the four post-docs, two are still there and neither is an under-represented minority. The data for the fifth column is entered as 2 (0). The remaining columns refer to the type of degree previously earned by these post-doctoral fellows in 1999, and the data in columns 6-8 must add up to the number of post-doctoral positions filled, given in the fourth column. In our example, of the four post-doctoral fellows, two were Ph.D.s, one of whom was an under-represented minority. The data for the sixth column are entered as 2 (1). One of the four post-doctoral fellows was an M.D./Ph.D. and two were M.D.s., and none of these were under-represented minorities, so the data for the seventh and eighth columns are entered as 1 (0) and 1 (0).

Again, please note that these data are not limited to the post-docs awarded a T32 slot; instead, this table is used to evaluate the post-doctoral fellows as a whole.

TABLE 3: Individual Qualifications of the T32 Trainees

NOTE WELL: This table requests information ONLY about individuals awarded T32 slots.

Table 3A - For T32 programs that train pre-doctoral candidates:

Describe the T32 trainees starting with the budget year that began May 2001 and continuing through all subsequent years. For each individual, list: year of entry into the program; their department or program; their previous institution, degree, and year of graduation; race, ethnicity and gender; GREs and/or MCATs; undergraduate GPA; and mentor’s name. At the bottom of these columns, indicate the average GRE and/or MCAT and average undergraduate GPAs. You may use numbers instead of names to protect the trainees privacy. If your T32 program trains ONLY pre-doctoral fellows, submit only Table 3A and not Table 3B.

Table 3B - For T32 programs that train post-doctoral fellows:

Describe the T32 trainees starting with the budget year that began May 2001 and continuing through all subsequent years. For each individual, list: year of entry into the program; their department or program; their previous institution (both degree granting and previous post-doctoral institutions should be given), degree, and year degree was granted; race, ethnicity and gender; and mentor’s name. GPA and GRE scores are not required for post-doctoral T32 trainees. If your T32 program trains ONLY post-doctoral fellows, submit only Table 3B and not Table 3A.

TABLE 4: Present Positions of T32 Trainees in the Last Ten Years

NOTE WELL: This table requests information ONLY about individuals selected for the T32 slots.

Table 4A - For T32 programs that train pre-doctoral candidates:

List alphabetically by mentor and then trainee, the present position and grant support of all pre-doctoral trainees who have completed or left the T32 training program in the last ten years, as well as trainees still in the training program (whether or not they are still hold a T32 slot). Include the training period and degree earned, if applicable, and the current position, including the institution or company, title, and date of appointment/employment. Indicate under-represented minority trainees with an asterisk (*). If a trainee is still in your training program, but is no longer supported through the T32, indicate their current source of support (e.g., R01 grant number) in the column Current Position . If your T32 program trains ONLY pre-doctoral fellows, submit only Table 4A and not Table 4B.

Table 4B - For T32 programs that train post-doctoral fellows:

List alphabetically by mentor and then by trainee, the present position and grant support of all post-doctoral trainees who have completed or left the T32 training program in the last ten years, as well as trainees still there (whether or not they are still hold a T32 slot). Include the training period and degree earned, if applicable, and the current position, including the institution or company, title, and date of appointment/employment. Indicate under-represented minority trainees with an asterisk (*). If a trainee is still there, but is no longer supported through the T32, indicate their current source of support (e.g., R01 or F32 grant number) in the column Current Position . If your T32 program trains ONLY post-doctoral fellows, submit only Table 4B and not Table 4A.

TABLE 5: T32 Trainee Publications

NOTE WELL: This table requests information ONLY about individuals awarded T32 slots.

Table 5A - For T32 programs that train pre-doctoral candidates:

For the past ten years, list all pre-doctoral trainees alphabetically, state the years in which they were supported by the T32, list their mentors, and list all of their publications associated with the T32 training program. Include all T32 trainees, even if they have no publications associated with the T32 training program. Clearly identify abstracts, and do not include manuscripts under review or in preparation. If your T32 program trains ONLY pre-doctoral fellows, submit only Table 5A and not Table 5B.

Table 5B - For T32 programs that train post-doctoral fellows:

For the past ten years, list all post-doctoral trainees alphabetically, state the years in which they were supported by the T32, list their mentors, and list all of their publications associated with the T32 training program. Include all T32 trainees, even if they have no publications associated with the T32 training program. Clearly identify abstracts, and do not include manuscripts under review or in preparation. If your T32 program trains ONLY post-doctoral fellows, submit only Table 5B and not Table 5A.

Plan for Sharing Research Data

Not applicable

Sharing Research Resources

Not applicable

Section V. Application Review Information

1. Criteria

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

The following will be considered in making funding decisions:

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

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique.
• Receive a second level of review by the National Advisory Child Health and Human Development Council.

Criteria for evaluating the competing continuation application for a second phase of the MENTOR Award are:

• Evidence of consistency in the overall design and goals
• The same or equivalently qualified program director and training faculty
• Demonstrated evidence of continued training success
• Evidence of a consistent or improving applicant population
• Demonstration of continued and improving attention to the needs of the program’s trainees and to the needs of the community, as defined in the description of the MENTOR Award (http://www.nichd.nih.gov/funding/mech_training.htm)

Trainee Recruitment, Selection, and Retention Plan: Are the quality of the applicant pool and plans for the selection and retention of individuals appointed to the training program appropriate? Specifically, what is the size and quality of the applicant pool? Are the recruiting procedures, trainee selection criteria, and retention strategies appropriate and well defined? Are there advertising plans or other effective strategies to recruit high-quality trainees?

• For competing renewal applications: How successful has the program been in efforts to recruit and retain individuals from diverse underrepresented populations?

Evaluation and Tracking Plan: Is the evaluation plan adequate and sufficiently detailed to track career outcomes of trainees and determine if the program is successful? Does it include a system for tracking participants following program completion, such as publications, grant proposals and awards, and career trajectory of supported trainees?

• For competing renewal applications: Are there plans to make changes that improve program performance and the assessment of outcomes? Competing renewal applications must describe the program accomplishments to date, following the application instructions on page 61 of the PHS 398 application, including the evaluation and outcome measures report described in Section IV.6 of this announcement as well.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support will be assessed in relation to the proposed research training program and the number of proposed trainees at the requested levels. The priority score should not be affected by the evaluation of the budget.

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.

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel’s evaluation will be included in an administrative note in the summary statement. 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: Peer reviewers will assess the applicant’s plan for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.

The plan will be discussed after the overall determination of merit, and the review panel’s evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable, and the result will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. The relevant NIH staff will judge the acceptability of the revised plan.

Following initial review: the appropriate NIH institute or center council, board, or other advisory group also reviews applications. These advisory groups will consider the assessment of the scientific and educational merit of the research training grant application as well as the initial review group’s comments on the Budget, Recruitment and Retention Plan to Enhance Diversity, and Training in the Responsible Conduct of Research.

2.C. Sharing Research Data

Not applicable

2.D. Sharing Research Resources

Not applicable

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information

1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

Special Administrative Requirements associated with NRSA programs:

Leave Policies: In general, trainees may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Trainees may receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Trainees may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the program director. A period of terminal leave is not permitted, and payment may not be made from traineeship funds for leave not taken. Trainees requiring periods of time away from their research training experience longer than specified here must seek approval from the NIH awarding component for an unpaid leave of absence. Trainees supported by academic institutions should refer to the NIH Institutional NRSA training grant guidelines at: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm for further guidance regarding vacations and requested leave.

Part-time Training: While NRSA trainees are required to pursue research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies, under unusual and pressing personal circumstances, a Program Director may submit a written request to the awarding component to change a trainee appointment to less than full-time. Such requests will be considered on a case-by-case basis and must be approved by the awarding Institute in advance for each budget period. The nature of the circumstances requiring part-time training might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission for part-time training will not be approved to accommodate other sources of funding, job opportunities, clinical practice, clinical training, or for other responsibilities associated with the trainee’s position at the institution. In each case, the Program Director must submit a written request countersigned by the trainee and an appropriate institutional business official that includes documentation supporting the need for part-time training The written request also must include an estimate of the expected duration of the period of part-time training, an assurance that the trainee intends to return to full-time training when that becomes possible, and an assurance that the trainee intends to complete the research training program. In no case will it be permissible for the trainee to be engaged in NRSA supported research training for less than 50% effort. Individuals who must reduce their commitment to less than 50% effort must take a leave-of-absence from NRSA training grant support. The stipend will be pro-rated in the grant award during the period of any approved part-time training. Part-time training may affect the rate of accrual or repayment of the service obligation for postdoctoral trainees.

Carryover of Unobligated Balances: The carryover of funds from one budget period to the next requires prior written approval by most of the NIH funding components. When required, such requests must include compelling justification including the status of trainee appointments to the program. If not stated on the Notice of Award, the Program Director should contact the applicable IC’s Grants Management contact to determine the funding IC’s carryover policy.

Termination of Award: When a grantee institution plans to terminate an award, the NIH funding component must be notified in writing as soon as possible.

Change of Institution: Awards are made to a specific institution for a specific research training program and the training program may not be transferred from one institution to another. Trainees seeking to change institutions must terminate their current appointment using the Termination Notice (form PHS 416-7, Rev. 10/05), located at http://grants.nih.gov/grants/forms/htm#training.

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

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

Service Payback Provisions: As specified in the NIH Revitalization Act of 1993, NRSA recipients incur a service payback obligation for the first 12 months of postdoctoral support. Additionally, the Act specifies that the second year of postdoctoral NRSA training will serve to pay back a postdoctoral service payback obligation. Accordingly, the following guidelines apply:

Postdoctoral trainees in the first 12 months of postdoctoral NRSA support must sign the Payback Agreement Form (PHS 6031) before initiating an appointment. Postdoctoral trainees in their first 12 months of support will incur a period of service payback obligation equal to the period of support.

Postdoctoral trainees in the 13th and subsequent months of NRSA postdoctoral support are not required to sign the payment agreement form and will not incur a service payback obligation for this period of support. In addition, the 13th and subsequent months of postdoctoral NRSA support are considered acceptable payback service for prior postdoctoral support. For example, postdoctoral trainees who continue under that award for two years have fulfilled the obligation incurred during the first 12 months of support by the end of the second year.

Service payback obligations can also be paid back after termination of NRSA support by conducting health-related research or teaching averaging at least 20 hours per week of a full work year. Payback service may be conducted in an academic, governmental, commercial, or nonacademic environment, in the United States or in a foreign country. Examples of acceptable payback service include research associateships/assistantships, postdoctoral research fellowships, and college or high school science teaching positions. Examples of unacceptable payback service include clinical practice and administrative responsibilities not directly related to scientific research
Recipients with service obligations must begin to provide acceptable payback service on a continuous basis within two years of termination of NRSA support. The period for undertaking payback service may be delayed for such reasons as temporary disability, completion of residency requirements, or completion of the requirements for a graduate degree. Requests for an extension must be made in writing to the NIH specifying the need for additional time and the length of the required extension.

Recipients of NRSA support are responsible for informing the NIH of changes in status or address.

For individuals who fail to fulfill their obligation through service, the United States is entitled to recover the total amount of NRSA funds paid to the individual for the obligated period plus interest at a rate determined by the Secretary of the Treasury. Financial payback must be completed within three years beginning on the date the United States becomes entitled to recover such amount.

Under certain conditions, the Secretary, DHHS (or those delegated this authority), may extend the period for starting service or repayment, permit breaks in service, or in rare cases in which service or financial repayment would constitute an extreme hardship, may waive or suspend the payback obligation of an individual. Detailed information on the accrual and repayment of the NRSA service payback obligation and waivers is available at: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm

Officials at the grantee institution have the responsibility of explaining the terms of the payback requirements to all prospective trainees before appointment to the training grant. Additionally, all trainees recruited into the training program must be provided with information related to the career options that might be available when they complete the program. The suitability of such career options as methods to satisfy the NRSA service payback obligation must be discussed.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and 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 (starting on page 19, Form 2590) should be followed. Note that a substitute budget page and a summary of trainee page are to be included in the request for continuation support. The non-competing budget page should list the names and levels of those trainees who are continuing in the research training program. Information on each trainee should also be included in the narrative portion of the progress report as described in the PHS Form 2590 instructions.

An evaluation and tracking report as described in Section IV.6. of this announcement should be included annually as part of the Progress Report.

Additional information that should be included in the annual progress report in concert with the PHS 2590 instructions:

• A brief introductory description of the program objective
• Information describing which, if any, faculty and/or mentors have left the program and which, if any, new individuals have been added; for new faculty and/or mentors involved in the program, biographical sketches should be included in the application.
• A detailed account of experiences in recruiting individuals from under-represented groups during the previous funding period must be included. Information must be included on both successful and unsuccessful recruitment strategies. The report should provide aggregated information of the racial/ethnic distribution of all applicants and those accepted and appointed. The aggregated report also should include information on individuals with disabilities and those from disadvantaged backgrounds. For those who were enrolled in the program, the report should include aggregated information about the duration of research training and whether those trainees completed their training in good standing.
• Any recommended changes to improve the program (e.g. new mentors, changes in courses, recruitment strategies, etc.)

Additional Reporting Requirements:

Financial Status Report (FSR): An annual FSR is required and must be submitted within 90 days of the end of each budget period. Continuation support will not be provided until the required form is submitted and accepted. .

Trainee Reporting Requirements: The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant. This form must be completed at the beginning of the initial appointment and annually thereafter. Additionally, a completed Payback Agreement Form (PHS 6031, Rev. 10/05) must be submitted for each postdoctoral trainee in his or her first 12 months of support. No funds may be provided until such documents are submitted and accepted by the funding Institute.

Within 30 days of the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS 416-7, Rev. 10/05) to the NIH. If the trainee has a payback obligation, he or she must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS 6031-1, Rev. 10/05) until the payback service obligation is satisfied. Failure by the grantee institution to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award. Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm.

Evaluation: In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this Program. Accordingly, recipients are hereby notified that they may be contacted during and after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the research training program.

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 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 (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.

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. Note that an evaluation and tracking report is required as part of the Final Progress Report.

Human Embryonic Stem Cells (hESC): Only approved hESC lines listed on the NIH Human Embryonic Stem Cell Registry http://stemcells.nih.gov/registry/ may be used for research training activities. The abstract of the application must provide the registry identifying numbers of the HESC lines to be used.

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:

Steven Klein, Ph.D.
National Institute of Child Health and Human Development
6100 Executive Boulevard, 4B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 496-5541
Email: kleins@mail.nih.gov

2. Peer Review Contacts:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: stretchr@mail.nih.gov

3. Financial or Grants Management Contacts:

Chris Robey
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6996
FAX: (301) 402-0915
Email: robeyJ@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

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