Department of Health and Human Services

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

Components of Participating Organizations
NIH Blueprint for Neuroscience Research (http://neuroscienceblueprint.nih.gov)  
National Center for Complementary and Alternative Medicine (NCCAM), (http://www.nccam.nih.gov/)
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov/)
National Eye Institute (NEI), (http://www.nei.nih.gov/)
National Institute on Aging (NIA), (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov/)
National Institute on Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov/)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov/)
National Institute on Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov/)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov/)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/ )
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR), (http://www.ninr.nih.gov/)
Office of Behavioral and Social Sciences Research (OBSSR), (http://obssr.od.nih.gov)

Title: Training in Translational Research in Neurobiology of Disease (T32)

Announcement Type
New

Request For Applications (RFA) Number: RFA-DA-06-008

Catalog of Federal Domestic Assistance Number(s)
93.213, 93.389, 93.867, 93.866, 93.272, 93.286, 93.865, 93.173, 93.121, 93.279, 93.894,  93.282, 93.853, 93.859, 93.361   

Key Dates
Release Date: November 9, 2005
Letters of Intent Receipt Date(s):  January 23, 2006
Application Receipt Dates(s):  February 22, 2006
Peer Review Date(s):  May/June 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: September 2006
Additional Information To Be Available Date (Url Activation Date): Not applicable.
Expiration Date:  February 23, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

• This RFA is an initiative of the NIH Blueprint for Neuroscience Research (http://neuroscienceblueprint.nih.gov), a trans-NIH partnership to accelerate neuroscience research.  Fifteen Institutes and Centers are participating in the Neuroscience Blueprint.  This RFA will be administered by NIDA on behalf of the Neuroscience Blueprint.
• The National Institutes of Health (NIH) will award Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants (T32) to eligible institutions to support research trainees in translational neurobiology of disease. Four types of full-time trainees may be supported: 1) Predoctoral Trainees in a neuroscience-oriented PhD or equivalent doctoral degree program; 2) Trainees in an accredited MD/PhD program at a medical school who will receive both an MD, DO, DDS, or equivalent professional degree and a PhD; 3) Short-Term Research Training for Health-Professional Students; and 4) Postdoctoral Trainees with research or clinical doctoral degrees to prepare for a research career in translational neuroscience.
• Applicant institutions may tailor their proposed program with a mix of trainee types with various levels of research experience. However, training programs are strongly encouraged to include concurrent training of both basic and clinical researchers.  The proposed training programs must be thematic, focusing not upon a specific disease but upon mechanisms that may be shared by a number of diseases and disorders and must include training in the progression of disease from molecules to behavior, to prevention or treatment.
• This program will support comprehensive training via basic neuroscience and neurobiology of disease courses, laboratory rotations, and classes at domestic non-profit institutions or domestic institutions of higher education, using the T32 funding mechanism.  Note that programs solely for short-term training should not apply to this announcement, but should consider the (T35) NRSA Short-Term Institutional program exclusively reserved for short-term programs (see http://grants.nih.gov/grants/guide/pa-files/PA-05-117.html).  Potential applicants for the T35 program are encouraged to contact appropriate staff in the relevant Institute or Center listed in the announcement prior to preparing an application to discuss issues of eligibility and review the specific provisions of this award.
• Because the nature and scope of the proposed research training will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the numbers, quality, duration, and costs of the applications received.
• Only domestic, non-profit, private or public institutions that have strong and high-quality research programs in the area (s) proposed for research training and have requisite staff and facilities may apply.
• The Program Director must be an established researcher with acknowledged accomplishments in basic or clinical neuroscience research and training. The applicant may also propose a Program Director Team. The Program Director or Program Director Team should provide the breadth of expertise and leadership needed to develop and implement the proposed training program.
• An external advisory committee is required.
• Awards for this T32 institutional NRSA research training grant are for a project period of up to five years duration.
• Training grant programs may not be transferred from one institution to another institution.
• An eligible institution (e.g., a university) may submit only a single application in response to this funding opportunity.
• Applications will not be accepted if they are essentially the same as currently pending applications or an application already reviewed.
• See Section IV.1 for application materials.
• Telecommunications for the hearing impaired is available at: TTY 301-451-5936

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

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

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

1. Research Objectives

Diseases of the nervous system pose a significant public health and economic challenge, affecting nearly one in three Americans at some point in their life, with a cost exceeding $500 billion per year. The National Institutes of Health (NIH) Blueprint for Neuroscience Research (http://neuroscienceblueprint.nih.gov/) is a collaborative and coordinated effort across 15 Institutes and Centers that supports research on the nervous system to accelerate the pace of discovery in neuroscience research. The ultimate goal of the Neuroscience Blueprint is to translate this new understanding into clinical interventions that will reduce the public health burden of nervous system disorders and maintain a healthy nervous system across the lifespan.  Over the past decade, driven by the emerging science, the NIH Institutes and Centers with an interest in neuroscience have increasingly joined forces through initiatives and through working groups on specific disorders. By pooling resources and expertise, the Neuroscience Blueprint can take advantage of economies of scale, confront challenges too large for any single Institute or Center, and develop research tools and infrastructure that will serve the entire neuroscience community.

In keeping with the goals of the Neuroscience Blueprint the participating NIH institutes are initiating a training program in translational research on the neurobiology of disease.  The aim of the program is to train scientists to identify and conduct research on neurobiological questions that are clinically relevant and to learn how to move the results and the knowledge gained from basic research into clinical and disease-oriented research, as well as to appreciate how findings in clinical research can serve to inform and refine basic research.  Programs funded through this initiative would include concurrent training of both basic and clinical researchers, with cross-training and information flow in both directions. The program is designed to support trainees at multiple stages in their careers, including PhD and MD/PhD students, postdoctoral fellows and short-term health-professional research trainees. The requirements, however, are intended to provide for sufficient flexibility to allow for applicant institutions to tailor their proposed program to best take advantage of the resources available to them.  The proposed training programs must be thematic, focusing not upon a specific disease but upon mechanisms that may be shared by a number of diseases and disorders and must include training in the progression of disease from molecules to behavior, to prevention or treatment.  The intent of this RFA is to support comprehensive, multidisciplinary research training. The translational training programs in the neurobiology of disease that will be developed will focus on training scientists to use the tools and techniques commonly applied to both basic and clinical research and across disciplines and NIH institute missions; scientists that can identify and appreciate mechanistic links and common biological themes that span disorders of the nervous system.  We encourage the development of innovative programs that accept trainees with varied research backgrounds, provide multiple tracks of research training tailored to participant research experiences that enhance each trainee's development of multidisciplinary knowledge and skills, and support opportunities for trainee interaction, research integration and collaborations.

It is expected that the training programs funded through this RFA would incorporate faculty and resources from several departments at the institution. Similar to the requirement for breadth in the levels of analysis, training should also expose students to a variety of disciplines. Successful programs should combine multiple approaches to the problems addressed, such as biochemical, genetic, pharmacological, computational, physiological, bioengineering, clinical, epidemiological, and utilize multiple model systems from, for example, in silico to in vitro, to animal, to human. It is expected that these training programs would also foster development of the research training infrastructure in neurobiology of disease at the institution, encourage collaborative research opportunities among the faculty, and collaborative efforts in training students, sponsoring visiting speakers, and hosting journal clubs and workshops. 

This initiative allows for innovative training programs to be proposed, with the intent being to allow applicants to tailor their program to best take advantage of the resources available to them. Suggested components include, but are not limited to:

Didactic Training: Didactic training, in the various formats chosen (e.g. courses, seminars, journal clubs, workshops, etc.), should include the contribution of different scientific disciplines, such as molecular biology, immunology, behavioral science, etc., to increasing our understanding of diseases of the nervous system. Broad areas might include brain function from the molecular to the behavioral level; the spectrum of clinical neurosciences, including ethical issues, clinical protocol design and statistics; the neurobiology of disease emphasizing etiologies and mechanisms that may be shared by diseases of the nervous system (such as neurodegeneration or developmental dysregulation) as well as the ways in which variants in disease mechanisms help define different diseases.  For more advanced trainees (e.g., postdoctoral), the curriculum may need to be customized based on each trainee’s background. The overall goal of the didactic training, regardless of the level of the trainee or the format and length of the didactics, should be scientists strongly versed in the breadth of neuroscience disease research.

Research: Full-time (i.e. not short-term) PhD, MD, DO, DDS, or equivalent degree students will be expected to gain broad research exposure. One mechanism to accomplish this could be laboratory rotations prior to the selection of a thesis advisor; however, other strategies may also be used. Mentorship by more than one faculty mentor, representing different disciplines or levels of analysis representative of both the basic and the clinical sciences is encouraged.

Short-Term Research Training for Health Professional Students: Programs for short-term research trainees (see Section III. 3. Other-Special Eligibility Criteria) should be tailored to the needs of each trainee based on his or her background. Whenever possible, however, they should benefit from the didactic and research infrastructure and collaborative opportunities afforded full-time trainees. Short-term research training should be of sufficient depth to enable trainees to have exposure to the principles underlying the conduct of research as well as the breadth of translational research on the diseases of the nervous system.

Applications may include a request for short-term predoctoral positions reserved specifically to provide full-time, health-related research training experiences during the summer or other “off-quarter” periods.  Such positions are limited to medical students, dental students, students in other health-professional programs, and graduate students in the physical or quantitative sciences.  Short-term appointments are intended to provide such students with opportunities to participate in research relevant to diseases of the nervous system in an effort to attract them into health-related research careers.  Short-term positions should be requested in the application and approved at the time of award.  Short-term positions are not to be used for individuals who have already earned a doctoral degree. Short-term research training positions should last at least 8 but no more than 12 weeks.  Individual health-professional students or students in the quantitative sciences selected for appointment should be encouraged to obtain multiple periods of short-term, health-related research training during the years leading to their degree.  Such appointments may be consecutive or may be reserved for summers or other "off-quarter" periods.

Collaboration: A specific objective of the program is that trainees should be prepared for research careers in which collaboration and integration across levels of analysis are key elements. Plans for fostering collaborative relationships during the training period, for trainees at all levels, should be addressed. For successful programs, it is expected that special efforts will be made to integrate the science, and the trainees, into a cohesive program where there is close and constant interchange of ideas, information, and training experiences.  If appropriate and viewed as beneficial to the goals of the program, collaborations with persons outside of the applicant institution are also encouraged. Although an application must be submitted by a single applicant institution, collaborative scientific arrangements with scientists from other institutions are encouraged if these arrangements are clearly delineated, and formally and officially confirmed by signed statements from the responsible officials of each institution. However, a full institutional commitment must come from the applicant institution. Brief periods of off-site training may be permitted (see Section VI. 2. Administrative and National Policy Requirements).

Collaborations may include international collaborations. However, this must represent a unique opportunity for both the US institution and the foreign institution. An international collaboration must present special opportunities for furthering the training and education programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that significantly augment existing U.S. resources. In addition, the special opportunity that this collaboration will afford the foreign training program should also be clearly described.

Transition: Another consideration is the duration of training and the transition of full-time trainees to individual support mechanisms.  The training grant Program Director or Program Director Team should limit appointments to individuals who are committed to a career in research and plan to remain on the training grant for the period specified by the category of trainee (see Section III. 3. Other-Special Eligibility Criteria).  The Program Director or Program Director Team should also encourage trainees to apply for subsequent support through the individual fellowships or mentored career development award (“K” ) programs. At the time of appointment, the Program Director or Program Director Team must provide NIH Institute or Center (IC) staff with the appointee’s name and contacting information and the name and contacting information for their mentor(s). Information regarding mentors should be sent in with the annual Progress Report to inform the Program Officer of the appointments/pairings and also become a part of the official grant file. Appointees and their mentors are hereby notified that they may be contacted during and after the completion of the award for the purposes of encouraging and assisting in career transition, evaluation and tracking (see Section IV. 6. Other Submission Requirements). Recipients of Kirschstein-NRSA support under this program announcement are responsible for informing the NIH of changes in name, status or address and this obligation continues for 5 years after the termination of appointment.

The Program Director or Program Director Team must develop methods for ongoing evaluation of the quality of the training program and develop plans to obtain feedback from former trainees to help identify weaknesses in the program and provide suggestions for program improvements.

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

1. Mechanism(s) of Support

This funding opportunity will use the Ruth L. Kirschstein National Research Service (T32) award mechanism.

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

This funding opportunity uses the non-modular budget format described in the PHS 398application 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.

2. Funds Available

• The NIH Blueprint for Neuroscience Research anticipates awarding up to $900,000 through this announcement
• It is anticipated that 2-3 awards will be made.
• The total costs of an individual award are not expected to exceed $300,000 in years 1 and 2, although they may increase during years 3, 4, and 5 as the program develops.
• Awards are anticipated to begin in September 2006 for a project period of up to five years.

Because the nature and scope of the proposed training programs will vary from application to application, it is anticipated that the size and duration of each award will also vary.  Although the financial plans of the Blueprint ICs are to provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Continuation of this pilot program beyond the initial five year period will be contingent upon the availability of funds and the Neuroscience Blueprint priorities.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

Allowable Costs

Grantees are expected to be familiar with and comply with applicable cost policies and the NRSA Guidelines (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm). Funds may be used only for those expenses that are directly related and necessary to the research training not otherwise available and must be expended in conformance with DHHS Cost Principles, the NIH Grants Policy Statement (rev. 12/01/2003), the NRSA regulations, policies, and guidelines, and conditions set forth in this document.

A. Stipends

The NIH will provide a stipend for each trainee position according to NIH guidelines and current stipend levels. The stipend is provided as a subsistence allowance for trainees to help defray living expenses during the research training experience. The stipend is not a payment for services performed. Stipends must be paid to all trainees at the level approved by the Secretary of the DHHS. Stipend levels are adjusted periodically, and current stipend levels are available on the NIH website at: http://grants.nih.gov/training/nrsa.htm. The total stipend must be based on a 12-month appointment. The institution may supplement, from non-Federal sources only, the NIH stipend up to a level that is consistent with the institution’s scale. The total stipend must be consistent with the level of effort, with the established stipend structure at the institution, and with stipends actually provided by the institution, from its own funds, to other staff members with equivalent qualifications, rank, and responsibilities in the same department.

Stipends for short-term research trainees will be based on a monthly proportion of the annual NIH stipend level at the time of award. The FY ’05 annual stipend level for a predoctoral trainee is $20,772, therefore the monthly stipend is $1,731 per month. For postdoctoral trainees, the annual stipend is determined based on the number of years of prior relevant postdoctoral experience at the time of the trainee’s appointment.

B. Tuition, Fees and Health Insurance

Applicant organizations can request funds for tuition. For the purposes of the NRSA programs, tuition is defined as the combined costs of tuition, fees and applicable health insurance.  Current NIH policies provide support to help offset the combined costs at the following rate: 100% of all costs up to $3,000 and 60% of costs above $3,000. Such costs will be provided according to existing NIH policies on Ruth L. Kirschstein Research Training Opportunities at the time of award. 

C. Trainee Travel

Applicants may also request funds for certain types of training-related travel for trainees (e.g., to attend professional meetings and other meetings directly related to their training). Annual levels are anticipated to be up to $750 per trainee. Note that travel to a research training site is not allowed unless there is an individual case of extreme hardship per NRSA policy on page 7 of the NRSA section in the NIH GPS). Travel expenses allowed while the short-term trainees are in the program are covered by the pro-rated stipend and the portion of the Training Related Expenses mentioned in D. below. Research training experiences away from the parent institution must be justified considering the type of opportunities for training available, the manner in which these opportunities differ from and complement those offered at the parent institution, and the relationship of the proposed experience to the trainee’s career stage and goals. This type of research training requires prior approval from the NIH. Letters requesting such training may be submitted to the NIH awarding component at any time during the award period. (See also Section VI. 2. Administrative and National Policy Requirements).

D. Training-Related Expenses

The applicant organization may also request funds for other Training-Related Expenses (TRE) such as personnel directing the program, consultants, project-specific supplies, travel, reproduction and printing costs, rental equipment, minor equipment items, and other items that are directly related to the recruitment, selection, placement, monitoring and retention of the trainees. Funds for such other training-related expenses are intended to provide the applicant with only partial support for the costs of the proposed research training and for meeting the costs of the trainees’ research projects. Under NRSA awards, up to $2,200 per predoctoral level trainee and $3,850 per postdoctoral trainee is currently provided on an annual basis for the other training-related expenses that are deemed essential to carry out the training program for the NRSA awardees appointed under the grant.

Under exceptional circumstances, which can include providing accommodations for a trainee with disabilities, or an exceptional research training experience at an off-site location, it is possible to request institutional costs above the standard rate. Requests for additional trainee costs must be explained in detail and carefully justified in the application. Consultation with NIH program staff in advance of such requests is strongly advised.

The type and amount of fiscal or in-kind costs to be contributed by the grantee organization should be identified and discussed in detail.

Short-Term Health Professional Research Trainees.

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, such as research supplies, tuition, fees, and certain types of travel and other expenses. The FY ’05 amounts for TRE are $2,200 annually ($183/month) for each predoctoral trainee and $3,850 annually ($322/month) for each postdoctoral trainee.

E. Facilities and Administrative (F&A) Costs

A facilities and administrative allowance based on 8% of total allowable direct costs (this excludes amounts for tuition, fees, health insurance, and 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 research training program.

Stipend Supplementation.

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

Compensation.

An institution may provide additional funds to a trainee in the form of compensation (as salary and/or tuition remission) for services such as teaching or serving as a research assistant. A trainee may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS research grant. However, compensated services should occur on a limited, part-time basis apart from the normal research training activities, which require a minimum of 40 hours per week. In addition, compensation may not be paid from a research grant that supports the same research that is part of the trainee’s planned training experience as approved in the institutional training grant application.

Educational Loans and G.I. Bill.

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

1. Eligible Applicants

1.A. Eligible Institutions

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

• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Domestic Institutions

Although foreign institutions are not eligible to apply as the applicant organization, such institutions may participate in this funding opportunity as a consortium organization.  When other sites are involved in the training program, the application must include a “resource format” page for each site.  Also, a complete description of any “foreign participation” must be included and fully justified to meet requirements for “foreign training.”

An eligible institution (e.g., a university) may submit only a single application in response to this funding opportunity. For the purposes of this RFA, components of a large or multi-component organization that are sufficiently independent to constitute, in effect, separate organizations are considered separate institutions. For example, the multiple campuses of the University of California system are considered separate institutions. However, the medical school, engineering school, dental school, etc., of a university, even if on different campuses, constitute a single institution. Multiple applications from different divisions, faculties, schools, centers, etc. at the same institution will not be reviewed.

The applicant institution must have strong research and training (graduate and postdoctoral) programs in the neurosciences, and must have the staff and available and adequate facilities required to conduct the proposed training program. Some staff and facilities may be made through consortium arrangements. The research training Program Director or Program Director Team at the applicant institution must be responsible for the recruitment, selection, direction, and evaluation of trainees to receive support and for the overall direction of the training program.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research 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 programs.

The Program Director must be an established researcher with acknowledged accomplishments in basic neuroscience or clinical research and training. The application may also propose a Program Director Team of co-investigators, with representation from the basic and clinical neurosciences.  The Program Director or Program Director Team should provide the breadth of expertise and leadership needed to develop and implement the proposed training program. The Program Director or Program Director Team members must each be willing to commit a minimum of 5% of their full-time professional effort to the training program for the period of the award. The Program Director or the Program Director Team will be responsible for providing administrative and scientific leadership for planning and directing the proposed training program, the recruitment, selection as well as the direction and supervision of trainees, and collecting and providing program evaluation and tracking information. Support of up to 5% of the total direct costs will be limited to the Program Director, or Program Director Team members only.

2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Responsiveness Criteria

The intent of this RFA is to establish training programs that are thematic, focused not upon a specific disease but on mechanisms that may be shared by a number of neuroscience diseases and disorders  It is incumbent upon the applicant to clearly delineate the thematic nature of the proposed training program and to provide evidence that the training provided through the program is broadly-based and the trainees will be prepared for translational research careers.

Applications lacking an evaluation plan will not be reviewed.

TRAINEE ELIGIBILITY REQUIREMENTS:

Citizenship

Individuals appointed to 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.

Trainees appointed to the research training program must have the opportunity to carry out supervised biomedical, behavioral, or clinical research with the primary objective of developing or enhancing their research skills and knowledge in preparation for a translational-oriented research career in the neurosciences.  Trainees must be able to commit full-time effort, normally defined as 40 hours per week, to the program and its related research activities, consonant with NRSA guidelines. Within the 40 hours per week 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. See Section I.V. 6. Special Program Requirements below for the NRSA policy on eligibility. Trainee candidates must be eligible for the full amount of training required as specified below.

Trainee positions on NRSA institutional grants may not be used for study leading to the MD, DDS., or other clinical, health-professional training except when those studies are part of a formal combined research degree program, such as the MD/PhD.  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.

Four types of trainees are eligible for support through this funding opportunity:

1) Full-Time Predoctoral Trainees

Predoctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA appointment, and must be training at the postbaccalaureate level and enrolled in a neuroscience-oriented program leading to a PhD in science or in an equivalent research doctoral degree program. Up to 5 years of support may be provided for each trainee. The goal is to prepare these students for independent careers in academia or industry as translational neuroscience researchers.

2) MD/PhD Students

Individuals must be in a combined MD/PhD program in which they will receive a PhD and a clinical doctoral degree or its equivalent. Illustrative examples of the clinical doctoral degree include, but are not limited to: MD, DDS., DMD, DO, DC, OD, ND (Doctor of Naturopathy), DVM. or PharmD.  MD/PhD students may be supported for up to 3 years during the PhD portion of their training. They must be enrolled in a neuroscience-oriented program leading to a PhD in science or in an equivalent research doctoral degree program. The goal for these students also is to prepare them for independent careers in academia or industry as translational neuroscience researchers.

3) Short-Term Health-Professional Research Trainees

To be eligible for short-term clinical 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 degree. Short-term research trainees are defined as medical, nursing, dental or allied health students who will spend summers or other blocks of time to gain full-time research experience and/or complete didactic course work in translational neuroscience. The goal is to expose clinical trainees with an interest in a research career to translational research in the neurobiology of disease, or to provide the training, experience, and incentives to allow them to participate in clinical research as medical practitioners. Clinical trainees in disciplines where their expertise is in demand (e.g. where there is a shortage), such as neuropathologists, are especially encouraged to enter this program. Short term positions must involve full-time (at least 40 hours per week) research training. Short-term research training may be used for graduate level health professional students who wish to gain research experience, to learn research methodologies, or who want to update their knowledge of new research techniques and findings. Individuals currently supported by other Federal funds are not eligible for duplicative trainee support from this program at the same time.

4) Postdoctoral Trainees

Postdoctoral trainees are trainees with research or clinical doctoral degrees who are interested in enhancing their research training and/or expanding their research training in an area or level of analysis that complements their prior research training and that prepares them for a research career in translational neuroscience. Postdoctoral trainees may receive up to 3 years of training in the program and must be eligible and willing to commit to a minimum of 2 years. Candidates must have received, as of the beginning date of the NRSA appointment, a PhD, MD, DDS, DVM, or comparable doctoral degree from an accredited domestic or foreign institution.  Eligible doctoral degrees include, but are not limited to, the following:  DMD, DC, DO, DVM, OD, DPM, ScD, EngD, DPH, DNSc, PharmD, ND (Doctor of Naturopathy), DSW,  PsyD, 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.

External Advisory Committee: An external advisory committee is required. It will be useful as the integrated training program is developed, implemented, and refined during the project period and will have a reporting function. Applicants should describe the types of persons who will be recruited for the External Advisory Committee and give details about when it will meet and the content of meetings, but should not name its members.  Applications without such information will be considered incomplete and not be reviewed.

Institutional Commitment: Applicant institutions should show commitment to the program’s goals and provide assurances that the institution intends the program to be an integral part of its research and research training endeavors.  The institution should provide evidence that it is committed to: (1) integrating this training program into the academic programs of the institution; (2) assuming responsibility for continued updating of the training program after the end of the project period; and (3) to continued evaluation of the training program after the end of the project period.  In addition, the institution should indicate plans for support of trainees participating in the training program after the end of the project period.

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

1. Address to Request Application Information

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

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 Applications, PHS 398, Section IV, which begins on page 54. 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.

See Section VI.2. Administrative and National Policy Requirements for additional information.

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

Letters of Intent Receipt Date(s):  January 23, 2006
Application Receipt Dates(s):  February 22, 2006
Peer Review Date(s):  May/June 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: September 2006

3.A.1. Letter of Intent

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

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

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

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

The letter of intent should be sent to:

Director - DA-06-008
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD  20892-8401
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application and the specific NRSA institutional grant application instructions that begin on page 54 of the PHS 398.  Submit a signed, typewritten original of the application, including the checklist, and three (3) 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 (2) additional copies of the application and all copies of the appendix material must be sent to:

Director - DA-06-008
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD  20892-8401
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-2755
FAX: (301) 443-0538
Email: [email protected]

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 Blueprint Neurobiology of Disease Training Project Team. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

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.

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.

6. Other Submission Requirements
Not applicable

Plan for Sharing Research Data
Not applicable

Sharing Research Resources
Not applicable

Special Program Requirements:

Research Training Program:  The program should provide didactic training as well as laboratory experience, including plans 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 take the information gleaned from the project to pursue future research.  The program should provide instruction and guidance in the process of applying for future support.

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

Past Training Record: The Program Director, Program Director Team and proposed preceptors, as a training faculty, should be able to demonstrate success in research training as determined by the success of former trainees in seeking further career development and in establishing productive scientific careers. Past training success may be documented by providing evidence of further career advancement of former trainees such as receipt of fellowships, career awards, further training appointments, and similar accomplishments, and/or evidence of a productive scientific career such as success in competing for research grants, receipt of special honors or awards, a record of publications, receipt of patents, promotion to scientific positions, or other accepted measures of advancement in a scientific career.

Trainee Appointments: All trainees are required to pursue their research training full time, defined as 40 hours per week.  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 award office based on a review of the written justification from the individual trainee, and endorsed by the Program Director or Program Director Team, and the sponsoring grantee institution.  Trainees seeking additional support are strongly advised to consult with the NIH awarding office.

Trainees supported by NRSA funds are not considered to be in an employer-employee relationship with NIH or the institution at which they are pursuing research training.

Research Environment/Resources:  The applicant institution must have a strong and high-quality research program in the area(s) proposed for research training and must have the requisite staff and facilities to carry out the proposed program. Describe the preceptors as researchers, including active research support directly related to the proposed research training program.  Identify mentors with expertise and experiences planned to support the number of trainees for which support is being requested.

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 or Program Director Team 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.

External Advisory Committee: An external advisory committee is required. The application should describe the planned role of the committee in guiding the development and maintenance of thee training program as well as the types of individuals that will be recruited for the committee to fulfill that role.  Committee members may include outside consultants or institutional consultants if deemed appropriate. The application should not name committee members.

Collaborative Agreements: Any arrangements for collaborative endeavors should be described and justified. Letters of Intent to Collaborate and Letters of Agreement from collaborators and consultants should be provided in the application prior to the checklist. Also, information must be included on the Resources Format page in the PHS 398 for each site participating in the 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 trainee termination from the program 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 that were supported by the program.  The application should provide a prospective evaluation plan for process and outcome measures.  Outcome measures must 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. Applications should break out these data by the applicable four types of trainees (see Section III. 3. Other-Special Eligibility Criteria). 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. As part of the evaluation plan, grantees must maintain for former trainees “seed data,” e. g. new name, contact information, place of employment, and type of career pursued for a 10-year period following their appointment to the training grant.

Recruitment Plan:  Applicants must submit a recruitment plan that include a scheme for recruiting trainees from both outside and inside their sponsoring institutions

Minority Recruitment and Retention Plan: The NIH remains committed to increasing the participation of individuals from underrepresented minority groups in biomedical and behavioral research.  As first announced in 1989, all competing applications for institutional NRSA research training grants must include a specific plan to recruit and retain underrepresented minorities in the training program. If an application is received without a plan, the application will be considered incomplete and will be returned to the applicant without review.  Additional information on this requirement was published in the NIH Guide for Grants and Contracts, Volume 22, Number 25, July 16, 1993 (see http://grants.nih.gov/grants/guide/notice-files/not93-188.html). 

A plan should also be included for the participation of individuals from underrepresented minority groups as Short-Term Health-Professional Trainees. This plan should be described separately, using the same categories of analysis. 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 minority recruitment plan after the overall score has been determined.  Reviewers will examine the strategies to be used in the recruitment of minorities.  The review panel’s evaluation will be included in an administrative note in the summary statement.  If the plan is judged to be unacceptable, funding will be withheld until a revised plan that addresses the deficiencies is received.  The Blueprint Computational Neuroscience Training Project Team, with guidance from the National Advisory Drug Abuse Council, will determine whether amended plans submitted after the initial review are acceptable.

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://grants.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.

Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Within the context of training in scientific integrity, it is also beneficial to discuss the relationship and the specific responsibilities of the institution and the graduate students or postdoctorates appointed to the program.

• Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, trainee attendance, and the frequency of instruction.
  
  
• The rationale for the proposed plan of instruction must be provided.
  
  
• Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in future competing continuation and noncompeting applications. The NIH encourages institutions to provide instruction in the responsible conduct of research to all graduate students, postdoctorates, and research staff regardless of their source of support.

Applications without plans for instruction in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review.

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

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by the CSR and responsiveness by the Blueprint Neurobiology of Disease Training Project Team in accordance with the review criteria stated below.

As part of the initial merit review, all applications:

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

The following will be considered in making funding decisions:

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

The goals of NIH-supported research training are to help ensure that basic and clinical researcher scientists are available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, behavioral, and clinical research needs. For this specific funding opportunity, these individuals must be highly trained in neuroscience and the neurobiology of disease, with cross-training or ‘translation’ in both directions between these research approaches. The scientific review group will determine the quality of the proposed research training program and consider whether the requested number of trainee positions is appropriate for the program.

Research training applications for this funding opportunity will be evaluated using the following criteria:

• Program Director or Program Director Team’s scientific background and administrative experiences; appropriateness to direct, manage, and administer the proposed research training program; adequate time planned to commit to directing the program.  
  
  
• Past research training record of the designated preceptors as determined by the success of former trainees in seeking further career development and in establishing productive scientific careers.  Evidence of further career development can include receipt of fellowships, career awards, further training appointments, and similar accomplishments.  Evidence of a productive scientific career can include a record of successful competition for research grants, receipt of special honors or awards, a record of publications, receipt of patents, promotion to scientific positions, and any other measure of success consistent with the nature and duration of the training received.
  
  
• Objectives, design, and direction of the research training program; quality of proposed course contents and training experiences for all levels of trainees to be included in the program; description of inter- and multi-disciplinary and inter-professional research training opportunities, or novel concepts, approaches, methodologies, or technologies to be utilized for the proposed research training program; description of the broad-based, thematic nature of the training to be provided and how that training will result in scientists prepared for a translational research career in the neurosciences.
  
  
• Caliber of preceptors as researchers, including successful competition for research support in areas directly related to the proposed research training program; sufficient number of mentors with sufficient expertise and experience to support the proposed number of trainees.
  
  
• Quality of the institutional training environment for NRSA supported trainees and the relationship of the NRSA program to the broader training program (if appropriate). The level of institutional commitment, quality of the facilities, availability of appropriate courses, and the availability of research and research training support; institution’s plan for the proposed program to be an integral component of its overall research program/mission.
  
  
• The adequacy of the plans for the composition of the External Advisory Committee and the plans for their role in the development and maintenance of the training program.
  
  
• Quality of the applicant pool and the selection of individuals for appointment to the training program.
  
  
• Quality of plans for promoting scientific interactions between basic and preclinical research in the training program.
  
  
• Quality of any arrangements for collaborative endeavors (if applicable).
  
  
• The adequacy of the proposed evaluation plan.

Short-Term Research Training Positions for Health-Professional students:

In addition to the above criteria, applications that request short-term research training positions will also be assessed using the following criteria:

• Quality of the proposed short-term research training program including the commitment and availability of the participating faculty, program design, availability of research support, and training environment;
  
  
• Access to candidates for short-term research training and the ability to recruit high quality, short-term clinical research trainees from the applicant institution or some other health-professional school;
  
  
• The potential of the research training program that to attract short-term clinical research trainees to careers in health-related research;
  
  
• Effect of the short-term training program on the quality of the regular research training program or any existing, stand-alone short- term research training program, including the appropriateness of the number of short-term positions, and the plan to integrate the short-term training program into the regular research training programs; and
  
  
• Quality of the plan to follow the careers of short-term clinical research trainees and to assess the effect of the training program on subsequent career choices.

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 in relation to the proposed research training program and number of proposed trainees at the various levels. The priority score should not be affected by the evaluation of the budget.

Minority Recruitment and Retention Plan:  Peer reviewers will separately evaluate the minority recruitment plans for the research education, training and career development components after the overall score has been determined. The review panel's evaluation will be included in an administrative note in the summary statement. If the plan for minority recruitment and retention is judged to be unacceptable, funding will be withheld until a revised plan that addresses the deficiencies is received.

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. The acceptability of the plan 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. Program staff will judge the acceptability of the revised plan.

Following initial peer review, the National Advisory Council on Drug Abuse also reviews applications.  These advisory groups will consider the assessment of the scientific and educational merit of the research training and education application as well as the initial review group’s comments on the recruitment of individuals from underrepresented minority groups and the plan for instruction in the responsible conduct of research.

2.C. Sharing Research Data
Not applicable

2.D. Sharing Research Resources
Not applicable  

3. Anticipated Announcement and Award Dates
Not applicable

1. Award Notices

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

2. Administrative and National Policy Requirements

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

Special Administrative Requirements associated with NRSA programs:

Leave Policies:  In general, trainees may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday.  Trainees may receive stipends for up to 15 calendar days of sick leave per year.  Sick leave may be used for the medical conditions related to pregnancy and childbirth.  Trainees may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the Program Director or Program Director Team.  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://grants.nih.gov/grants/guide/pa-files/PA-02-109.html for further guidance regarding vacations and requested leave. 

Part-time Training:  Under unusual and pressing personal circumstances, a Program Director or Program Director Team 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 or Program Director Team 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. 

Off-Site Training: Training in another institution may be permitted if directly related to the purpose of the award and offers opportunities not available at the applicant institution. Only local, institutional approval is required if such training does not exceed three months. Exceptions are if costs will be above those at the grantee institution or if it is at a foreign institution. For these situations or for longer periods, prior written approval of IC staff is required. To obtain prior approval, the Program Director or Program Director Team must submit a letter to the IC describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the off-site training is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the award will continue during such training, provided that it relates to the specific training program supported by this initiative.

Service Payback Provisions:  As specified in the NIH Revitalization Act of 1993, Kirschstein-NRSA recipients incur a service payback obligation only during the first 12 months of postdoctoral support.  Additionally, the Act specifies that the second and subsequent years 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 more than 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 under this program announcement are responsible for informing the NIH of changes in name, status or address and this obligation continues for 15 years after the termination of appointment.

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://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131.

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.

Carryover of Unobligated Balances: The carryover of funds from one budget period to the next requires prior written approval.  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 or Program Director Team 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: 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), located at http://grants.nih.gov/grants/forms.htm#training.

Change of Program:  Awards are made to a specific institution for a specific program under the guidance and leadership of a particular TPD.  A change in any of these parameters requires prior approval by program staff of the NIH funding component.  A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program.  If the new program does not satisfy this requirement, the award will be terminated.  

Change of Training Program Director: If change of a Training Program Director is necessary, support of the award is not automatic but may be continued with prior written approval 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 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 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.

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

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.

This NRSA program is not subject to SNAP.

Progress Reports

The annual progress report should provide information about changes in the integrated program, a summary report by the Advisory Committee, and a description of the research and career progress of each trainee.  These annual progress reports will be closely monitored by the Blueprint Training Project Team to ensure that the grant is achieving the goals of the overall Program.  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 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. 

Expand the application for continuation to contain the following information:

• A brief introductory description reiterating the program objectives and research training and education components, with summary information on the integrated program;
  
  
• A summary table delineating which faculty, mentors, and Advisory Committee members have left the program and which, if any, new individuals have been added or are taking their places.  Include for each person his/her degree and departmental affiliation (or equivalent);
  
  
• Biographical sketches of new participating faculty, mentors, and Advisory Committee members;
  
  
• Evaluation and tracking report;
  
  
• A detailed account of experiences in recruiting individuals from under-represented groups during the previous funding period must be included.  Information must document both successful and unsuccessful recruitment strategies.  The report should provide aggregated information of the racial/ethnic distribution of all applicants and those accepted and appointed.  For those who were enrolled in the program, the report should include aggregated information about the duration of research training and whether those trainees completed their training in good standing;
  
  
• Progress of individual trainees: A brief paragraph for each trainee describing the research and didactic training experiences completed and ongoing, as well as specific future plans for satisfying the requirements of the program;
  
  
• Any recommended changes to improve the program (e.g. new faculty or mentors, changes in didactic components or programmatic activities, changes in core requirements, recruitment strategies, etc.);
  
  
• A report from the Advisory Committee that is separately attached summarizing its actions during the last year, evaluating the performance of the program in meeting its objectives and intent, evaluating the effectiveness of recruitment strategies (provide a separate evaluation for minority recruitment), and providing recommendations for improving the program (e.g. new mentors, changes in core requirements, changes in recruitment strategies, etc.)

Additional Reporting Requirements:

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

Trainee Reporting Requirements:  The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant.  This Form must be completed at the beginning of the initial appointment and annually thereafter.  Additionally, a completed Payback Agreement Form (PHS 6031) 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) 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) until the payback service obligation is satisfied.  Failure 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 Blueprint may request information essential to an assessment of the effectiveness of this Program.  Accordingly, recipients are hereby notified that they may be contacted during and after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contacts, honors and awards, professional activities, and other information helpful in evaluating the impact of the Program. 

Publication and Sharing of Research Results:  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 project was supported by NIH grant number ______ which is part of the NIH Blueprint for Neuroscience Research.”  Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.

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.

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:

Suman Rao King, Ph.D.
Office of Science Policy and Communications
National Institute on Drug Abuse/NIH/DHHS
Suite 5230, MSC 9591
6001 Executive Boulevard
Bethesda, MD 20892-9591
Telephone: (301) 443-6071
FAX: (301) 443-6277
Email: [email protected]

Andrew A. Monjan, Ph.D., M.P.H.
Chief, Neurobiology of Aging Branch
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging/NIH/DHHS
Gateway Building, Suite 350
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD  20892-9205  (use 20814 for express mail)
Telephone:  (301) 496-9350
FAX:  (301) 496-1494
Email: [email protected]

2. Peer Review Contacts:

Teresa Levitin, Ph.D.
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD  20892-8401
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  [email protected]

3. Financial or Grants Management Contacts:

Deborah S. Wertz
Senior Grants Management Specialist
Grants Management Branch/OPRM
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 270
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]

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.

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

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

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

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

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

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

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

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual 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://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

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

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

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

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