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EXPIRED

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

Announcement Type
New

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

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.

Program Announcement (PA) Number: PAR-08-054

Catalog of Federal Domestic Assistance Number:
93.865

Key Dates
Release Date: December 18, 2008
Letters of Intent Submission Dates: April 25, 2008, 2009 and 2010
Application Submission Dates: Standard NIH T32 dates; May 25, 2008, 2009 and 2010
Peer Review Date: October/ November 2008, 2009, and 2010
Council Review Dates: January 2009, 2010 and 2011
Earliest Anticipated Start Dates: April 2009, 2010 and 2011
Additional Information To Be Available Date (URL Activation Date): Not applicable
Expiration Date: (Now Expired March 24, 2010 per NOT-OD-10-069), May 26, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Training 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
A. Submission, 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
1. Program Contact
2. Peer Review Contact
3. Grants Management Contact

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Training Objectives

The objective of this NRSA T32 program is to provide research training to predoctoral students interested in establishing research careers that use systems biology approaches to study developmental biology and the formation of structural birth defects.

Background and Purpose

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

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

Accordingly, this PA encourages applications for interdisciplinary NRSA T32s to train advanced predoctoral graduate students in Systems Biology and Developmental Biology. These T32s should be designed to teach each student to use the approaches of Systems Biology to study Developmental Biology and/or the formation of birth defects. These programs will help ensure that the next generations of researchers will have the skills needed to significantly advance our understanding of normal developmental processes and of the processes that lead to structural birth defects. This FOA addresses the recommendations of a panel of experts who recently advised NICHD on future research priorities for Developmental Biology (see

http://www.nichd.nih.gov/publications/pubs_details.cfm?from=&pubs_id=5672). Their recommendations included targeting training programs to specific research areas, such as systems biology or quantitative aspects of development.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NRSA T32 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed research training program. Awards may be made for periods up to 5 years and are renewable.

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

2. Funds Available

Because the nature and scope of the training proposed in each application may vary, it is anticipated that the size of each award will also vary. Although NICHD’s financial plans provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Grantees are expected to be familiar with and comply with applicable costs policies and the NRSA Guidelines (http://grant.nih.gov/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 to help defray trainees living expenses during the research training experience. The stipend is not a payment for services performed. Trainees are not considered to be employees of the Federal Government or of the grantee institution. The total stipend is based on a full time12-month 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. Stipends may be adjusted only at the time of appointment or reappointment and may not be changed in the middle of an appointment period. Stipends are based on the annual NIH stipend levels at the time of award. For example, the fiscal year 2007 annual stipend level for a predoctoral trainee was $20,772. Current NRSA Stipend Levels are listed at http://grants1.nih.gov/training/nrsa.htm#inst .

B. Tuition and Fees

Funds are provided to offset the cost of tuition and fees. Request the actual amounts needed for each student. The NIH provides 60% of the combined requested costs, up to $16,000 annually per Ph. D. student, and up to $21,000 annually for students in formal programs leading to combined professional and Ph. D. degrees (e.g., M.D.-Ph.D., D.D.S.-Ph.D.).

These costs are allowable only if they are required for specific courses as part of the approved research training program and are applied consistently to all students in a similar research training status at the institution regardless of the source of support. A full description of the NIH tuition policy is at

http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html

C. Trainee Travel

Allowable costs include travel expenses for students to attend scientific meetings and workshops that the program determines to be necessary for their training experience. Funds can not be used to cover the costs of travel between the trainee’s residence and the training institution, except that the grantee organization may authorize a one-way travel allowance in an individual case of extreme hardship. NICHD will provide up to $750 per trainee annually for travel expenses.

Additionally, support for travel to a training experience away from the institution may be permitted. A training experience away from the parent organization must be justified based on the type of opportunity available, how it differs from and complements 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 NICHD, and, if not known at the time of application, may be submitted at any time during the award period.

D. Trainee Related Expenses (including health insurance)

The applicant institution may request the NIH standard NRSA Training Related Expenses (FY 2007, $4,200 annually for each predoctoral trainee) to help defray other research training expenses, such as health insurance (either self-only or family as appropriate), staff salaries, consultant costs, equipment, research supplies, and faculty/staff travel directly related to the research training program (see http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html for additional information). Funds are provided as a lump sum on the basis of the predetermined amount per trainee approved for support.

Under exceptional circumstances, which can include accommodating a trainee’s disabilities, 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 NICHD program staff in advance of such requests is strongly advised.

E. Facilities and Administrative Allowance

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

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.

A. Stipend Supplementation. The grantee institution may provide stipend supplementation or additional support to offset the cost of living. Supplementation does not require additional effort from the trainee. DHHS funds may not be used for supplementation under any circumstances. Additionally, no funds from other Federal agencies may be used for supplementation unless specifically authorized by the NIH and the other Federal agency.

B. Compensation. An institution may provide additional funds to a trainee in the form of compensation (as salary and/or tuition remission) for services 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 research training activities, which require a minimum of 40 hours per week. 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.

C. Educational Loans and G.I. Bill. An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

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

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research training program is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are always encouraged to apply for NIH support.

The training program director should be an established researcher with a successful training record and available resources to conduct the proposed training program. They will be responsible for selecting and appointing eligible trainees, for directing, managing and administering the program, for evaluating the program, and for submitting all required forms in a timely manner.

2. Cost Sharing or Matching

Not applicable

3. Other-Special Eligibility Criteria

Eligible Trainees

Trainees appointed to the training program must be advanced graduate students who are committed to a doctoral dissertation project in systems biology of developmental biology/birth defects research. They must have the opportunity to carry out supervised research with the primary objective of developing their research skills and knowledge of these areas of research. 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.

At the time of appointment to the training program, students 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 support. In addition, trainees must be able to commit full-time effort in the program at the time of appointment.

At the time of appointment to the training program, students must have received a baccalaureate degree, must be training at the post-baccalaureate level, and be enrolled in a program leading to a Ph.D. in science or in an equivalent research doctoral degree program. Health-professional students and graduate students in the quantitative sciences who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs are also eligible. A T32 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.

Section IV. Application and Submission Information

1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

Applications must be prepared using the current PHS 398 research grant application instructions and forms (http://grants.nih.gov/grants/funding/phs398/phs398.pdf.). Applicants must use the T32 guidelines and the specific instructions for Institutional NRSA Applications. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Special Program Requirements

A. Trainee Appointments

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

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

B. Recruitment

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

C. Evaluation

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

3. Submission Dates

3.A. Submission, Review and Anticipated Start Dates
Letters of Intent Submission Dates: April 25, 2008, 2009, 2010
Application Submission Dates: Standard NIH T32 dates apply; May 25, 2008, 2009, 2010
Peer Review Dates: October/ November 2008, 2009, 2010
Council Review Dates: January 2009, 2010 and 2011
Earliest Anticipated Start Dates: April 2009, 2010, 2011

3.A.1. Letter of Intent

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

Descriptive title of proposed training program

Name, address, and telephone number of the Principal Investigator

Names of other key personnel

Participating institutions

Number and title of this funding opportunity

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains will allow NICHD staff to estimate the review workload and plan the review.

The letter of intent may be e-mailed to:

James Coulombe, Ph.D.
Developmental Biology, Genetics and Teratology, NICHD, NIH
301 496 5541
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the NRSA instructions in the PHS 398 research grant application forms as described above. 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 not 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 H. 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 courier or express service)
Telephone: 301 496-1485
FAX: 301 402-4104
Email: [email protected]

3.C. Application Processing

Applications must be submitted on or before the application submission dates listed above (Section IV.3.A.). Upon receipt, applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement, http://grants.nih.gov/grants/policy/policy.htm. The section of the NIH Grants Policy Statement regarding Ruth L. Kirschstein National Research Service Awards may be found at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm#_Toc54600204.

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 Liability

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 regulations do not apply to or impact NRSA programs or awards. An NRSA stipend is provided by the NIH as a subsistence allowance for 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.

6. Other Submission Requirements

Special Instructions for Applications Requesting $500,000 (direct costs) or More Per Year

Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs) must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

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

3) Include the PHS398 Cover Letter component with the application to identify the staff member and IC who agreed to accept assignment of the application.

This policy applies to all new applications, competing renewal (formerly competing continuation ) applications, resubmission (formerly revised/amended ) applications, and revision (formerly competing supplemental ) applications. See NOT-OD-02-004, October 16, 2001.

Supplemental Application Instructions

The following information, including the suggested tables, should be provided IN ADDITION to that specified in the PHS 398 instructions for institutional National Research Service Awards.

Special Requirements

1. Research Training Program. The program should admit only advanced graduate students who are committed to a doctoral dissertation project. Appointed students should have prior training in either systems biology, or in developmental biology/birth defects research. The program should devise a strategy to provide each student with a research experience that combines systems biology with developmental biology/birth defects research. It should include a plan for determining trainees experience and needs, and for monitoring progress to accomplish the desired goals. The program should provide didactic training as well as a laboratory or clinical research experience. It should also provide its trainees with professional development skills and career guidance including instruction and training in grant writing in order to apply successfully for future career development and independent research support.

2. Training Faculty. Describe the membership of the participating departments/programs, including the participating faculty members research area, research support and participation in other training grants. Describe the past research training record of the faculty members participating in this program.
See suggested tables 1 5 at http://publications.nigms.nih.gov/nrsa/NewPredoctoralTraining.htm.

3. Training Record and Available Trainees. Justify the number of trainee positions requested based on the available pool of eligible trainees, the training faculty, and the training track record. Describe the success of the former trainees of the participating faculty, including successful completion of programs and further career advancement, such as receipt of fellowships, career awards, further training appointments and similar accomplishments. Describe former trainees competition for research grants, receipt of special honors or awards, record of publication, promotion to scientific positions, and any other accepted measures of success consistent with the nature and duration of the training period. Characterize the students who recently applied to and were accepted into the participating departments/programs, including those who are underrepresented minorities.
See suggested tables 6 - 10 at http://publications.nigms.nih.gov/nrsa/NewPredoctoralTraining.htm.

4. Institutional Commitment. The administration of the applicant institution as well as the participating departments/programs should describe their support for the goals of the training program. This description could include financial and non-financial support, such as, space, shared laboratory facilities and equipment, funds for curriculum development, release time for the Program Director or participating faculty, support for additional trainees in the program, or any other creative mechanisms to improve the climate for the establishment and growth of the training program.

5. Evaluation and Tracking Component. The application must describe an evaluation and tracking component to review the effectiveness of all aspects of the program. Describe a system for tracking trainees for a 10-year period following program completion to determine the program’s effectiveness. This tracking should include information on the former trainees publications, grant proposals, and awards, and career trajectory. The application should provide a prospective evaluation plan for process and outcome measures. Outcome measures may include relevant positions obtained, current activities related to research, publication record, and the success rate of applying for and obtaining Federal and non-Federal research grant support. The evaluation and tracking report should be included annually as part of the Progress Report, in future competing continuation applications, and as part of the Final Progress Report.

6. Recruitment and Retention Plan to Enhance Diversity. Applicants must submit a recruitment plan for recruiting trainees from both outside and inside their sponsoring institutions. The application should describe any recruitment and outreach plan to increase the depth and diversity of the applicant pool including those underrepresented in the current scientific research workforce in the area of the proposed research training. This Program Announcement requires all applicants to submit a recruitment and retention plan to enhance diversity. Applications without a plan will be considered incomplete and will not be reviewed.

The NIH recognizes a unique and compelling need to promote diversity in the scientific 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 sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27). 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/index.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.

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Their 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 an acceptable plan (and report) is received. NICHD, with guidance from its national advisory council as needed, will determine whether amended plans and reports submitted after the initial review are acceptable.

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

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

7. Training in the Responsible Conduct of Research. Every trainee supported by an NRSA T32 must receive instruction in the responsible conduct of research. Applications must include a description of a program to provide formal or informal instruction in scientific integrity and ethical principles in research. For more information on this provision, see http://grants1.nih.gov/grants/guide/notice-files/not92-236.html. Applications that do not include plans to provide instruction in the responsible conduct of research will be considered incomplete and will not be reviewed.

Plan for Sharing Research Data

Not applicable

Sharing Research Resources

Not applicable

Section V. Application Review Information

1. Criteria

(Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

The NICHD will convene an appropriate peer review group to perform the initial merit review according to the review criteria listed below.

As part of the initial merit review, all applications:

Subsequent funding decisions will be based upon:

Review Criteria

The goal of NIH-supported research training is to help ensure an adequate and diverse pool of highly trained scientists to address the Nation’s biomedical, behavioral, and clinical research needs. The peer review group will consider the following criteria to assign the application’s overall score, weighting them as appropriate for each application. Reviewers will first determine the quality of the proposed research training program and then consider whether the requested number of trainee positions is appropriate for the program.

Training Program: Does the program’s design ensure that each student will receive training in both systems biology and in developmental biology/ birth defects research? Is there a viable strategy to tailor the program to the needs of each student by taking their previous training into consideration? Does the program propose novel and creative strategies that will enable each student to perform a dissertation project that combines both areas of research? Will students who graduate from this program be able to perform independent projects that combine both areas of research?

Training Program Director: Does the Program Director have the scientific background, expertise, and experience appropriate to direct, manage, coordinate, and administer the proposed research training program? Does the Program Director plan to commit adequate time to the program?

Preceptors/Mentors: Is the caliber of preceptors/mentors as researchers, including successful competition for research support in pertinent areas of research, appropriate for their role in the training program? Is there a sufficient number of experienced mentors with appropriate expertise and funding available at the applicant institution to support the number of trainees and levels of trainees being proposed in the application?

Training Record: Is the training record of the program, the Program Director, and designated preceptors/mentors appropriate? How successful are former trainees in seeking further career development and in establishing productive scientific careers? Is there evidence of successful completion of the program, receipt of subsequent fellowships and/or career awards, further training appointments, and similar accomplishments? Is there evidence of a productive scientific career, such as a record of successful competition for research grants, receipt of honors or award, a record of publications, promotion to scientific positions, and any other measure of success consistent with the nature and duration of the training received. What is the track record of proposed mentors in similar research training programs?

Institutional Training Environment, Commitment and Resources: Is the quality of the research environment for the proposed training program appropriate? Is the level of institutional commitment, quality of available facilities, courses, research and research training support suitable? Is the proposed program to be an integral component of the applicant institution’s overall research program/mission?

Applicant Recruitment, Selection, and Retention: 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?

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?

2.A. Additional Review Criteria

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

Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

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

These items will be considered after the priority scored is determined.

Budget: Is the requested number of students and the requested period of support appropriate based upon the size and qualifications of the applicant pool, upon the training record and upon the number and quality of the training faculty? The reviews evaluation will be included in an administrative note in the summary statement.

Recruitment and Retention Plan to Enhance Diversity: Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups (defined in section IV, 6.6, above). The reviews evaluation as to whether these plans are acceptable or unacceptable 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 an acceptable plan is received. NICHD staff, with guidance from their national advisory 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 application’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. These 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 an acceptable plan is received. NICHD staff will determine the acceptability of the revised plan.

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 Program Director will be able to access the written critique called a Summary Statement via the eRA Commons.

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

Carryover of Unobligated Balances: NICHD requires prior written approval for carryover of funds from one budget period to the next. Such requests must include compelling justification including the status of trainee appointments to the program.

Termination of Award: NICHD must be notified in writing as soon as possible if a grantee institution plans to terminate an award.

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 is necessary, support of the award is not automatic but may be continued with prior written approval from NICHD, 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 NICHD program and grants management staff 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 goals 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 NICHD program staff. If the new program does not satisfy this requirement, the award will be terminated.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, 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.

Follow the NRSA instructions for the non-competing grant progress report. 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:

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. 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.

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

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

Trainees are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from a trainee’s research, NIH support should be acknowledged by a footnote in language similar to the following: This investigation was supported by the National Institute of Child Health and Human Development under Ruth L. Kirschstein National Research Service Award (number). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NICHD. 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 or programmatic, peer review, and financial or grants management issues:

1. Program Contact:

James Coulombe, Ph.D.
Developmental Biology, Genetics and Teratology Branch
Center for Developmental Biology & Perinatal Medicine
National Institute of Child Health & Human Development
6100 Executive Blvd., 4B01 MSC 7510
Bethesda, MD 20892-7510
(Rockville, MD 20852 for courier or express service)
Telephone: (301) 496-5541
FAX: (301) 480-0303
Email: [email protected]

2. Peer Review Contact:

Robert H. 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 courier or express service)
Telephone: 301 496-1485
FAX: 301 402-4104
Email: [email protected]

3. Grants Management Contact:

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

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

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

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

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

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

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

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

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

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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

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NIH Funding Opportunities and Notices


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