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 Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov)
National Human Genome Research Institute (NHGRI), (http://www.nhgri.nih.gov)

Title: Human Genes and the Environment Research Training Program (T32)

Announcement Type
New

Request For Applications (RFA) Number: RFA-ES-07-002

Catalog of Federal Domestic Assistance Number(s)
93.113, 93172

Key Dates
Release Date: January 17, 2007
Letters of Intent Receipt Date(s): May 29, 2007
Application Receipt Date(s): June 29, 2007
Peer Review Date(s): October-November 2007
Council Review Date(s):  January 2008
Earliest Anticipated Start Date: July 1, 2008
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: June 30, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary  

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Training Objectives

Section II. Award Information
  1. Mechanism(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 Training Objectives

Background

In February 2006 two new, closely related and complementary initiatives were announced to speed up research on the causes of common diseases. The first initiative, the Genetic Association Information Network (GAIN), is a study to determine the genetic contributions to common diseases and is supported through a public-private partnership.  The second initiative, the Genes and Environment Initiative (GEI) combines genetic analyses with environmental technology development to understand the causes of common diseases and is supported by the NIH.    The goals of the Genes and the Environment Initiative are two-fold: (1) to advance our understanding of common diseases and (2) to develop new technology to inform about point of contact exposures (environmental sensors), biological response indicators (biological sensors), and measures of diet, physical activity and psychosocial stressors.  In addition, this arm of the GEI proposes programs in biomarker development and validation, development of data repositories, and data integration. 

The Exposure Biology Workshop was held in May, 2006, to identify research opportunities which might be pursued within the Genes and the Environment Initiative to develop better approaches and technology to measure environmental exposures (cite website for summary of workshop).   There was general agreement at the meeting that a research training program with a new focus was needed.  The emphasis would be to train scientists in the emerging field of environmental genomics/genetics who will pursue a career path that integrates environmental sciences with human genetics and population genetics/genomics.  Because large-scale studies will be needed, the understanding of genetic and genomic technologies will be essential.  Inclusion of other clinical and patient-oriented research components will also be necessary to provide the framework to approach problems of etiology and treatment of complex diseases. 

NIH has supported the development of important resources to support these initiatives.  With respect to research, the NHGRI has supported the development of many genomic resources to facilitate our understanding of genetic variation, such as the sequence of the human genome and the genomes of several mammalian and non-mammalian organisms, the human HapMap Project, high throughput genotyping methods, cost effective DNA sequencing technologies, etc.   Likewise, the NIEHS has supported the development of  methodologies to measure both exposures and biological consequences of environmental exposures through its research grants, the Superfund Basic Research Program and the National Center for Toxicogenomics, which had the goal of facilitating the application of gene and protein technology, gaining an understanding of the relationship between environmental exposures and human disease susceptibility, and the identification of useful biomarkers of disease and exposure to toxic substances.  With respect to multi-disciplinary training, NHGRI and NIEHS jointly sponsored a training program in Genomic Analysis that was aimed at developing a cadre of scientists at the interface of biological and computational disciplines who could make advances in the development of new research tools, and computational approaches.

Specific Objectives:

This new Human Genes and the Environment Research Training Program seeks to build upon the established foundations in exposure biology and high throughput genomics and expands the base to include additional scientific disciplines, such as human genetics, population genetics/genomics, statistics, epidemiology, environmental genomics/genetics, mechanistic environmental health sciences, systems biology, metabolomics, engineering, computational biology, behavioral medicine, other clinical and biomedical elements, and other relevant areas, to define a new interdisciplinary science which can address the relative roles of genes and environmental exposures in complex diseases.  The goal is to produce a new generation of scientists who are equally at home in genomics and environmental health sciences and can seamlessly interact with both groups of scientists.  This cadre of scientists will not only be equipped to advance methodologies and technologies in Environmental Genomics/Genetics, but also use these tools and resources to disentangle and evaluate the enormous number of environmental factors which directly influence or interact with some genotypes to determine the resultant phenotypic expression and clinical or physiologic endpoints.

Applicants to the program will need to elaborate their vision of the shared conceptual framework to the Human Genes and the Environment Research Training Program and identify a focus or theme within the research training needs of the larger interdiscipline that the proposed research training program intends to address.  Each research training program is expected to build upon the research, faculty, didactic, infrastructure and grant support strengths of the Institution and meld these elements into a cohesive training experience. 

New curricula will be needed as an anchor to define and unify the research training programs.  Each program should identify and define some knowledge base for all individuals trained by the program, including new coursework, seminars, and other curricular elements designed for the research training program.  The curriculum is expected to maximize Institutional resources within the institutional setting.  Curriculum content for the programs supported under this program announcement, including newly designed coursework, are not expected to be uniform across programs, but each application should propose a method of communication and exchange of curriculum content across program sites.

Research training programs are expected to have a primary and predominant focus on training researchers to address problems of human health, complex human diseases, and human biology, and the main elements of the program should consist of relevant research in human genetics/genomics and exposure biology/exposure technology to better measure human exposures and explain how they interact with genetic factors to cause disease.  Inclusion of research in comparative genomics for cross species comparisons or animal models to perfect exposure technology must be justified on the basis of specific disease and clinical endpoints and the theme of the research training program. 

Partnerships with the industrial sector are encouraged.  Industrial partners can offer unique resources to the training environment, such as laboratory rotations, faculty, and research projects.  Training programs are also encouraged to utilize environmental exposure data bases (OSHA, NIOSH, and proprietary data) as a resource for informatics.

Research training programs in Human Genes and the Environment will support trainees at the predoctoral and postdoctoral level and may include short-term training experiences.   The focus of the predoctoral program should be on completion of a high quality thesis research project consistent with the goals of the program announcement, along with the core curriculum and other didactic content appropriate to the degree.  Applicants should describe the desired quantitative and biological backgrounds necessary for individuals to be recruited into the program.  Postdoctoral training should focus on attracting trainees with degrees relevant to exposure biology/environmental health sciences or genomics/genetics who wish to emphasize research and training experiences in the cross training area and/or trainees with clinical degrees who wish to engage in research in environmental genomic/genetics.  Postdoctoral programs must be well defined and should include didactic experiences needed for trainees to achieve the defined knowledge base for the program.  Short-term training experience can support either professional students or graduate students with backgrounds in quantitative sciences, engineering, environmental health sciences, genomics or genetics, who wish to engage in a cross-training experience in the opposite field.  Inclusion of physicians and other clinically trained individuals at all levels of the program is encouraged.

Research training programs submitted in response to this Program Announcement will be assigned to either the NIEHS or the NHGRI for funding purposes, but will be considered a programmatic unit for purposes of scientific administration and coordination, joint program directors meetings, etc.

No application submitted in response to this announcement should duplicate research training provided in any other funded program.  Overlap with portions of other programs should be addressed in the application, and if an application in response to this program is funded, the corresponding training slots in the other funded application will be deleted.

Programs should include training in the responsible conduct of research, in regulatory oversight involved in performing human subjects research and in the ethical, legal and social implications of human genetics research.

Programs are to be structured so that each trainee is supervised by a mentoring team of at least two mentors, one of whom has expertise in the relevant environmental exposure or exposure biology aspect of the research and the other having relevant genetic/genomic expertise.  The mentoring team should also be structured to include someone who can provide expertise and guidance in the relevant clinical or disease endpoint of the research so that trainees can be fully aware of the impact of their research on the ultimate endpoint of human health or disease.

Research training grant applications should outline an appropriate governance structure, including Co-Directors with complementary research and training experience in the environmental health sciences and in human genomics/genetics.  It is recommended that research training programs include a dedicated governance committee for the program which would participate in making decisions regarding trainee selection, appointment, and retention and outline criteria by which faculty will be selected and retained as mentors for the training program.  Programs may elect to form an external advisory committee, but this is not required.

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 Ruth L. Kirschstein National Research Service Award (NRSA) T32 award mechanism.  Awards may be made for periods up to 5 years and are renewable.

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 described in the PHS 398 application instructions. 

2. Funds Available

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 and Fees:

Tuition and fees will be reimbursed at an amount per predoctoral trainee equivalent to 60% of the level requested by the applicant Institution, up to $16,000 per year.  If the program supports formally combined dual-degree training (e.g., M.D.-Ph.D., D.D.S.-Ph.D.), the amount provided per trainee will be up to $21,000 per year.  An amount per postdoctoral trainee equal to 60% of the level requested by the applicant institution, up to $4,500 per year, will be provided.  If the program supports postdoctoral individuals in formal degree-granting training, the amount provided per trainee enrolled in a degree-granting program will be up to $16,000 per year.   The NIH tuition policy is in http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html.

 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. 

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.

Trainee travel funds  up to $800 per predoctoral FTE and up to $1200 per postdoctoral FTE may be requested.  In addition, travel funds of up to $1000 each for the Training Director and Co-Director may be included in the budget for attendance at the annual meeting for this Training Program.

D. Training Related Expense (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.

The Training Related Expenses category has been modified to include health insurance as an allowable expense.  An additional $2,000 per predoctoral trainee, per year, and an additional $4,000 per postdoctoral trainee per year, are provided to this category.  This category continues to be referred to as training related expenses but now includes health insurance as an allowable cost.  See:  http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-093html

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.  

In order to support the development and initiation of the didactic component of this program, the Program Director may request up to an additional $7,000 in year one  and up to an additional $5,000 in year two, to be budgeted in the training related expenses category.  These additional funds are intended for course development, will be restricted for this use, and may not be rebudgeted without prior approval.  Applicants must address how the course will be updated in future years absent additional funds.  In subsequent years, the standard NIH formula will be applied.

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/archive/grants/policy/nihgps_2003/index.htm

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

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:

Only domestic, non-profit, public or private institutions/organizations are eligible to apply for the institutional NRSA research training grants.  Foreign institutions are not eligible to apply.

The applicant institution must have strong research programs in both human genetics/genomics and the environmental health sciences, and must have the staff and facilities on site required to conduct both predoctoral and postdoctoral research training.

An eligible institution (e.g., a university) may only submit a single application in response to this funding opportunity and may only have a single training program supported by this funding opportunity at one time.  Multiple applications from different divisions, faculties, schools, centers, etc., at the same university will be returned without further consideration by the NIH.  The intent of the funding opportunity is to define a new interdiscipline, therefore applications which propose support for a training program which is essentially the same as an ongoing program will not be considered responsive to the funding opportunity.  It is the responsibility of the applicant to justify uniqueness of the training program proposed.

1.B. Eligible Individuals

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

The Training Program Director and Co-Director will be responsible for planning, directing and executing the proposed training program.  The Training Program Director and Co-Director should be established researchers with acknowledged and complementary accomplishments in human genomics and in the environmental health sciences, and should be capable of providing both administrative and scientific leadership to the proposed research training program.

2. Cost Sharing or Matching

Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing

3.  Other-Special Eligibility Criteria

Responsiveness Criteria

An applicant institution may only submit one application in response to this announcement. 

Applicants are required to outline a program which includes both pre and postdoctoral training.  Inclusion of short-term training opportunities within the training program is encouraged, but not required.  If it is included, a full description of the program, including recruitment and selection criteria, should be included.

Curriculum development for the Human Genes and the Environment Training Program is a required element of the funding opportunity.

Programs to be assigned to the NIEHS will also need to conform to the Restructuring Notice NOT-ES-06-007 (http://grants1.nih.gov/grants/guide/notice-files/NOT-ES-06-007.html)

Research Training Program

Trainees appointed to the research training program must have the opportunity to carry out supervised research responsive to the interdiscipline defined in this Human Genes and the Environment Research Training Program with the primary objective of developing their research skills and knowledge in preparation for a career in health related 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. Within the full-time training period, research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience.

A Kirschstein-NRSA institutional research training grant must be used to support a program of full-time research training.   It may not be used to support studies leading to the M.D., D.D.S., or other clinical, health-professional training except when those studies are part of a formal combined research degree program, such as the M.D./Ph.D.  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 Kirschstein-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 post-baccalaureate level, and be enrolled in a program leading to a Ph.D. in science or in an equivalent research doctoral degree program.  Health-professional students, graduate students in the quantitative sciences, or individuals in postgraduate clinical training who wish to interrupt their studies for a year or more to engage in full-time research training before competing their formal training programs are also eligible.

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.

Short-Term Health-Professional Trainees:

A Kirschstein NRSA-Institutional Research training application may include a request for short-term positions reserved specifically to provide full-time health-related research training experiences during the summer or other “off-quarter” period.  Such positions are limited to medical students, dental students, students in other health-professional programs, graduate students in the physical or quantitative sciences or students in either the environmental health sciences or genomics/genetics who wish research experience in the other discipline.  Short-term appointments under T32 research training programs are intended to provide such students with opportunities to participate in biomedical or behavioral research in an effort to attract these individuals into research careers. To be eligible for short-term predoctoral research training positions, students must be enrolled and in good standing and must have completed at least one quarter in a program leading to a clinical doctorate or a masters or doctorate in a quantitative science such as physics, mathematics, or engineering prior to participating in the program.  Individuals already matriculated in a formal research degree program in the health sciences, or those holding a research doctorate or master’s degree or a combined health-professional/research doctorate normally are not eligible for short-term training positions.  Within schools of pharmacy only individuals who are candidates for the Pharm.D. degree are eligible for short-term research training positions.

Short -term positions can support individuals for a period at least 8, but no more than 12 weeks in a grant year, and must involve full-time research training, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. 

Funding for short-term training is prorated, based on the allowed annual amounts for stipends and training related expenses.  Individuals currently supported by other Federal funds are not eligible for duplicative trainee support from this program at the same time.

NOTE:  applications requesting funds for solely short-term research training programs may not apply to this Program Announcement, but instead for the T35 Program Announcement, http://grants.nih.gov/grants/guide/pa-files/PA-05-117.html

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) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

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

3. Submission Dates and Times

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

Letter of Intent Receipt Date: May 29, 2007
Application Receipt Date(s): June 29, 2007
Peer Review Date: October-November 2007 
Council Review Date: January 2008
Earliest Anticipated Start Date: July 1, 2008

3.A.1. Letter of Intent

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

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:

Linda K. Bass, PhD
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-23
111 T. W. Alexander Drive
Research Triangle Park, NC  27709
Telephone: (919) 541-1307
Fax:  (919) 541-2503
Email:  bass@niehs.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research training grant applications found in the PHS 398 instructions for preparing a research grant application, Section IV. 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:

Linda K. Bass, PhD
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-23
111 T. W. Alexander Drive
Research Triangle Park, NC  27709
Telephone: (919) 541-1307
Fax:  (919) 541-2503
Email:  bass@niehs.nih.gov

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.). 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 NIEHS. Incomplete and non-responsive applications will not be reviewed.  If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle.

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/archive/grants/policy/nihgps_2003/index.htm.

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

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

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

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

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

Annual Meetings:  For coordination of the program as an initiative, which crosses institute missions, annual meetings may be held.  Applications should budget for one annual meeting per year for the Director and Co-Director.
Curriculum Development and Maintenance:  Funds are available in the RFA in years one and two specifically for the development of curriculum to support the training program.  Applicants should address the resources and mechanisms to support, maintain and update the curriculum in subsequent years.

Research Training Program:  The program should plan to provide didactic training as well as laboratory or clinical research experience.  This should include a plan for determining trainee experience and needs and monitoring progress to accomplish desired goals.  The program should develop trainee skills in understanding research, applying their critical abilities to conduct research, identify problems in the process of conducting research, raise questions and propose solutions to resolving problems.  Trainees should be prepared to utilize their research findings as they pursue future research.  Programs should provide all NRSA trainees with additional professional development skills and career guidance including instruction and training in grant writing in order to apply successfully for future career development and independent research support.  All postdoctoral NRSA trainees should also be provided with instruction in laboratory and project management.

Program Director:  The Program Director must possess the scientific background and leadership and administrative capabilities required to coordinate, supervise, and direct the proposed research training program.  The Program Director will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program.  Program Directors must provide potential trainees information associated with NRSA programs and submit all required trainee forms in a timely manner.

Past Training Record:  This should describe the past research training record of the  Program Director, and designated preceptors/mentors.  The information should describe the success of former trainees of the designated preceptors/mentors in seeking further career development and in establishing productive scientific careers.  Evidence can include successful completion of programs, further career advancement of former trainees such as receipt of fellowships, careers awards, further training appointments and similar accomplishments.  Evidence of a productive scientific career can include a record of successful competition for research grants, receipt of special honors or awards, a record of publications, receipt of patents, promotion to scientific positions, and any other accepted measures of success consistent with the nature and duration of the training period.  
Trainee Appointments:   All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies.  Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the NIH awarding unit, or when trainees are appointed to approved, short-term training positions.

No individual trainee may receive more than 5 years of aggregate NRSA support at the predoctoral level or 3 years of support at the postdoctoral level, including any combination of support from institutional training and individual fellowship awards.  Any exception to the maximum period of support requires a waiver from  the NIH awarding office based on a review of the written justification from the individual trainee, and endorsed by the Program Director and the sponsoring grantee institution.  Trainees seeking additional support are strongly advised to consult with the NIH awarding office.

Research Environment/resources:  The applicant institution must have a strong and high-quality research program in both exposure biology/environmental health sciences and in human genomics/genetics and must have the requisite staff and facilities to carry out the proposed program.

Institutional Commitment:  The applicant institution should include information that documents a commitment to the proposed research training program’s goals, and provide assurance that the institution intends the program to be an integral part of its research and research training endeavor.  The application should include a description of support (financial or otherwise) to be provided to the program, which could include, for example, space, shared laboratory facilities and equipment, funds for curriculum development, release time for the Program Director and participating faculty, support for additional trainees in the program, or any other creative ways to improve and enhance the growth of the research training program.

Evaluation and Tracking Component:  The application must describe a strong evaluation and tracking component that will review and determine the effectiveness of all aspects of the program.  This should include a system for tracking trainees for a 10-year period following their completion of the program completion to determine success or failure of the program. The follow up tracking would include information on program publications, grant proposals, and awards, and career trajectory of trainees who were supported by the program.  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.

Recruitment Plan:  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.

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

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

A.      Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/)  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.

Competing new and non-competing 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.

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.  

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.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the NIEHS or the NHGRI) on the basis of established PHS referral guidelines.  Scientific review will be conducted by the NIEHS Scientific Review Branch, in conjunction with appropriate NHGRI input.

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

The following will be considered in making funding decisions:

The goals of NIH-supported research training are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, behavioral, and clinical research needs. The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application.  Reviewers will first determine the quality of the proposed research training program and then consider whether the requested number of trainee positions is appropriate for the program.

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

Training Program:  Are the objectives, design and direction of the proposed research training program appropriate?  Does the proposed program provide suitable training for the levels of trainees being proposed and the area of science to be supported by the program?  Is the quality of proposed course contents and training experience appropriate for all levels of trainees to be included in the program?   Are inter- and multi-disciplinary and inter-professional research training opportunities or novel concepts, approaches, methodologies, or technologies appropriately utilized?  Does the program content have the potential to accomplish the intent of the training goals of this program?

Training Program Director:  Do the Program Director and Co-Director have the scientific background, expertise, and experience appropriate to direct, manage, coordinate, and administer the proposed research training program? Do the Program Director and Co-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 areas directly related to the proposed research training program 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?

Past Training Record:  Is the past research training record of  the Program Director, and designated preceptors/mentors appropriate to the proposed training program?  How successful are former trainees in seeking further career development and in establishing productive scientific careers in areas relevant to the proposed training program?  Is there evidence of successful completion of programs, 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 special honors or award, a record of publications, receipt of patents, 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? Is there a record in retaining health-professional postdoctorates (i.e., individuals with the M.D., D.O, D.D.S. D.N.Sc., etc.) for at least 2 years in research training or other research activities, if appropriate?

Institutional Training Environment, Commitment, and Resources:  Is the quality of the research environment for the proposed research training program appropriate? Is the level of institutional commitment, 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? 

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?

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?  

Short-Term Research Training Positions*: In addition to the above criteria, applications that request short-term research training positions will also be assessed using the following criteria:

NOTE:  applications requesting funds for solely short-term research training programs may not apply to this Program Announcement, but instead for the T35 Program Announcement, http://grants.nih.gov/grants/guide/pa-files/PA-05-117.html

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.

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/archive/grants/policy/nihgps_2003/index.htm).

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

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

2. Administrative and National Policy Requirements

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

Special Administrative Requirements associated with NRSA programs:

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

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

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

Termination of Award:  When a grantee institution plans to terminate an award, the 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, Kirschstein-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 Kirschstein-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 Kirschstein-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 Kirschstein-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 Kirschstein-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 Kirschstein-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 Kirschstein-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 Kirschstein-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 Kirschstein-NRSA service payback obligation and waivers is available at: http://grants1.nih.gov/archive/grants/policy/nihgps_2003/index.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 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:

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 and submitted to the NIH awarding component 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 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 Institutes of Health under Ruth L. Kirschstein National Research Service Award (number).    Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.”  In addition, federal funding must be acknowledged as provided in “Public Policy Requirements and Objectives-Availability of Information-Acknowledgment of Federal Funding.”

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:

NIEHS:

Carol Shreffler, Ph.D.
Division of Extramural Research
National Institute of Environmental health Sciences, EC-23
Building 4401, Room 3411
P.O. Box 12233

Research Triangle Park, NC  27709
Telephone: (919) 541-1445
Fax:  919-541-5064
Email:  shreffl1@niehs.nih.gov

NHGRI:

Bettie Graham, Ph.D
Division of Extramural Research
National Human Genome Research Institute
Building 5635, Room 4076
5635 Fishers Lane
Rockville, MD  20892
Telephone:  (301) 496-7531
Fax:  (301) 480-2770
Email:  grahamb@nhgri.nih.gov

2. Peer Review Contacts:

Linda K. Bass, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-23
111 T. W. Alexander Drive
Research Triangle Park, NC  27709
Telephone: (919) 541-1307
Fax:  (919) 541-2503
Email:  bass@niehs.nih.gov

3. Financial or Grants Management Contacts:

NIEHS:

Lerlita Garcia
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
PO Box 12233
Research Triangle Park, NC 27709
Telephone: (919) 316-4638
Fax: (919) 541-2843
Email: garcia1@niehs.nih.gov

NHGRI:

Cheryl Chick
Grants Administration Branch
National Human Genome Research Institute, NIH
Telephone: (301) 435-7858
Fax: (301) 402-1951
E-mail: cc149o@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/archive/archive/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 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).

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 RFA 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 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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