Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
Trans-NIH Jointly Sponsored T32 Training Committee:
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 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 Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Eye Institute (NEI), (http://www.nei.nih.gov)
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.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 Dietary Supplements (ODS), (http://ods.od.nih.gov)

Title: Jointly Sponsored Ruth L. Kirschstein National Research Service Award Institutional Predoctoral Training Program in the Neurosciences

Announcement Type
This is a reissue of PAR-02-017 that was previously released November 6, 2001.

Update: The following updates relating to this announcement have been issued:

Program Announcement (PA) Number: PAR-05-055

Catalog of Federal Domestic Assistance Number(s)
93.866, 93.865, 93.173, 93.278, 93.867, 93.859, 93.282, 93.853, 93.272

Key Dates
Release Date: February 18, 2005
Letters of Intent Receipt Date(s): April 10, 2005; April 10, 2006; April 25, 2007
Application Receipt Dates(s): May 10, 2005; May 10, 2006; May 25, 2007
Peer Review Date(s): October/November
Council Review Date(s): January/February
Earliest Anticipated Start Date: July 1, 2006; July 1, 2007; July 1, 2008
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: January 3, 2008

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

  Section I. Funding Opportunity Description
    1. Research 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
      A. Cooperative Agreement Terms and Conditions of Award
        1. Principal Investigator Rights and Responsibilities
        2. NIH Responsibilities
        3. Collaborative Responsibilities
        4. Arbitration Process
    3. Reporting

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

  Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

In keeping with the goals of the newly announced NIH Blueprint for Neuroscience Research (http://neuroscienceblueprint.nih.gov), the National Institute on Aging (NIA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Child Health and Human Development (NICHD), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute on Drug Abuse (NIDA), National Eye Institute (NEI), National Institute of General Medical Sciences (NIGMS), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), and the Office of Dietary Supplements (ODS) are continuing joint sponsorship of a predoctoral institutional research training program in the neurosciences. The aim of the program is to encourage and support broad, early-stage (pre-dissertation) training in the neurosciences by offering institutions a single, comprehensive training grant. This program supports the early years of graduate training, typically the first and second years, before full-time thesis research begins. Trainees are expected to be participants in a formal predoctoral curriculum offering broad and fundamental training in the neurosciences. We encourage a curriculum that spans the breadth of neurosciences in terms of the level of analysis (genes to molecules to cells to integrated, functional systems), approaches (including translational research), and the neuroscience of disease and disorders. The training program would include core courses, laboratory rotations, and programmatic activities, but would exclude full-time dissertation research. It is expected that these institutional training programs will contribute to basic and disease-related neuroscience research that is relevant to the participating NIH Institutes.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the Ruth L. Kirschstein National Research Service (T32) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

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

Institutional NRSA research training grants (T32) may be made for periods up to five years and are renewable. Awards within an approved competitive segment are normally made in 12-month increments; support for additional years is based on satisfactory progress and the continued availability of funds.

2. Funds Available

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

Allowable Costs

A. Stipends

The NIH will provide a stipend for each trainee position according to NIH guidelines. 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. Trainees are not considered to be employees of the PHS or their sponsoring organization. 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. For fiscal year 2005, the annual stipend for predoctoral trainees is $20,772.

B. Tuition

Applicant organizations can request funds for tuition. For the purposes of this program announcement, tuition is defined as the combined costs of tuition, fees and applicable health insurance. The NIH will 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 - National Research Service Award Research Training Grants and Fellowships, at the following website: http://grants.nih.gov/training/nrsa.htm. A full description of the tuition policy may be found in the NRSA Grants Policy Statement on the NIH website at: http://grants.nih.gov/grants/policy/nihgps_2003.

C. 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 predoctoral trainee. In addition, support for travel to a research training experience away from the institution may be permitted. 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.

D. Training-Related Expenses (See correction, NOT-MH-05-009)

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 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.

Funds to support travel (travel plus one day per diem) of the Program Director to the Program Directors' meeting in the Washington, DC area every other year should be requested in the TRE category.

Under exceptional circumstances, which can include providing accommodations for a trainee with disabilities, 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.

Grantees are expected to be familiar with and comply with applicable cost policies and the NRSA Guidelines. 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 and guidelines, and conditions set forth in this document.

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.

Stipend Supplementation, Compensation, And Other Income

The grantee institution is allowed to provide funds to an individual in addition to the stipends paid by the NIH. Such additional amounts either may be in the form of augmented stipends (supplementation) or in the form of compensation, such as salary or tuition remission for services such as teaching or serving as a laboratory assistant, provided the conditions described below are met. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the trainee's approved NRSA training program.

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

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

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

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

An eligible institution (e.g., a university) may only submit a single application in response to this funding opportunity and may only have a single training program supported by this funding opportunity at one time. Multiple applications from different divisions, faculties, schools, centers, etc. at the same university will be returned without further consideration by the NIH.

The applicant institution must have a strong research program in the neurosciences and must have the staff and facilities required to conduct the proposed predoctoral 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 Training Program Director will be responsible for planning, directing, and executing the proposed training program. The Training Program Director should be an established researcher with acknowledged accomplishments in neuroscience research and training, and should be capable of providing both administrative and scientific leadership to the proposed training program.

2. Cost Sharing or Matching

Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

Responsiveness Criteria

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

Because this funding opportunity only supports predoctoral training in the neurosciences, applications requesting support for both predoctoral and postdoctoral trainees will be deemed unresponsive and will be returned to the applicant without review.

Eligible Trainees

Trainees appointed to the training program must have the opportunity to carry out supervised neuroscience research with the primary objective of developing their research skills and knowledge in preparation for a career in neuroscience research.

At the time of appointment to the training program, individuals selected to participate in these training programs must be citizens or non-citizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence and have in their possession an Alien Registration Receipt Card (I-151 or I-551) or other legal verification of admission for permanent residence. Non-citizen nationals are persons born in lands that are not States but are under U.S. sovereignty, jurisdiction, or administration (e.g., American Samoa). Individuals on temporary or student visas are not eligible for NRSA support. In addition, trainees must be able to commit full-time effort in the program at the time of appointment.

Predoctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA appointment, and must be training at a postbaccalaureate level and enrolled in a program leading to a Ph.D. in neuroscience, an equivalent research doctoral degree program, or a combined clinical degree and Ph.D., such as M.D./Ph.D. Students enrolled in health-professional programs that are not part of a formal, combined program and who wish to postpone their professional studies to gain research experience, may also be appointed to a Kirschstein-NRSA institutional research training grant.

Individuals currently supported by other Federal funds are not eligible for trainee support from these programs at the same time. Further, NRSA traineeships are not given for study leading to a M.D., D.O., D.D.S., or other similar professional clinical degree, or master's clinical degree.

Additional information may be obtained in the NRSA Guidelines at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm#_Toc54600187.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

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

Special Program Requirements

A. Trainee Appointments

Trainees are customarily appointed for full-time, 12-month continuous periods. No trainee may be appointed for less than nine months during the initial period of appointment except with prior approval of the NIH program staff. All trainees are required to pursue their research training on a full-time basis, at a minimum of 40 hours per week. The amount of the stipend and tuition (defined for the purposes of NRSA as the cumulative amount of tuition, all fees, and health insurance) for each full appointment period must be obligated from funds available at the time the individual begins training. See http://grants.nih.gov/grants/guide/notice-files/not96-020.html for additional details on allowable stipend/tuition fees.

By law, an individual trainee may receive no more than five years of NRSA support in the aggregate at the predoctoral level, including any combination of support from institutional training grants and individual fellowship awards. Exceptions to this limitation require a waiver from the director of the funding Institute based on a review of the justification provided by the awardee, and must be submitted for prior written approval.

B. Recruitment

The primary objective of the NRSA program is to prepare qualified individuals for careers that have a significant impact on the Nation's research agenda. Within the framework of this program's longstanding commitment to excellence and projected need for investigators in particular areas of research, attention must be given to recruiting individuals from racial or ethnic groups underrepresented in the biomedical and behavioral sciences. The following groups have been identified as underrepresented in biomedical and behavioral research nationally: African Americans, Hispanic Americans, Native Americans, Alaskan Natives, and Pacific Islanders. Use of the term "minority" in this announcement will refer to these groups.

C. Evaluation

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

D. Program Director Meeting

Program Directors are required to attend a one-day meeting with other Program Directors and NIH staff in the Washington, DC area every other year. At this workshop, Program Directors will be asked to report on successes or problems in their training programs, and NIH staff will provide briefings on new training and career development opportunities through the participating NIH Institutes. Funds to cover the costs of travel to this meeting should be requested in the budget under Training-Related Expenses (Section II.2.)

3. Submission Dates and Times
Applications must be postmarked by the submission dates described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: April 10, 2005; April 10, 2006; April 10, 2007
Application Receipt Date(s): May 10, 2005; May 10, 2006; May 10, 2007
Peer Review Date: October/November
Council Review Date: January/February
Earliest Anticipated Start Date: July 1, 2006; July 1, 2007; July 1, 2008

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to: (Contact updated, see NOT-GM-06-001)

Alison Cole , Ph.D.
Deputy Assistant Director for Research Training
National Institute of General Medical Sciences
45 Center Drive , Room 2AS-49K, MSC 6200
Bethesda , MD 20892-6200
Telephone: (301) 594-3827
FAX: (301) 480-2802
Email: colea@nigms.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist and five 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)

3.C. Application Processing

Applications must be postmarked by the submission dates 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 CSR and responsiveness by the trans-NIH Jointly Sponsored T32 Training Committee.

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. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

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 (see also Section VI.3. Reporting).

The section in the NIH Grants Policy Statement regarding Ruth L. Kirschstein National Research Service Awards may be found at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm#_Toc54600204.

Concurrent Awards

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

Tax Liability

Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-514, 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 taxability of stipends, however, in no way alters the relationship between NRSA trainees and institutions. NRSA stipends are not considered salaries. In addition, trainees supported under the NRSA are not considered to be in an employer-employee relationship with NIH or the institution in which they are pursuing research training. Therefore, it is inappropriate and unallowable for institutions to seek funds for or to charge institutional research training grant awards for costs that would normally be associated with employee benefits (e.g., FICA, workman's compensation, and unemployment insurance).

It must be emphasized that the interpretation and implementation of the tax laws are the domain of the Internal Revenue Service (IRS) and the courts. PHS takes no position on what the status may be for a particular taxpayer, and it does not have the authority to dispense advice to trainees or institutions about their tax liability. Individuals should consult their local IRS office about the applicability of the law to their situation and for information on their tax obligations.

6. Other Submission Requirements

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

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

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

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

This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

Plan for Sharing Research Data
Not applicable.

Sharing Research Resources
Not applicable.

Supplemental Application Instructions

Supplemental application instructions, including suggested tables, should be requested from one of the program staff listed below (Section VII.1).

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

Special Programmatic Requirements

1. Research Training Program. The aim of the Jointly Sponsored NIH Predoctoral Training Program in the Neurosciences is to support broad, early-stage training in the neurosciences by offering institutions a single comprehensive training grant. The training programs are expected to facilitate training students in basic and disease-related neuroscience research that is relevant to the participating NIH Institutes. The training programs must ensure that there are ongoing research programs available to trainees in areas relevant to the missions of one or more of the sponsoring NIH Institutes. Only early predoctoral training is supported under this funding opportunity. For the purposes of this funding opportunity, early predoctoral training typically spans the first and second years of graduate training and is restricted to that training occurring before full-time thesis research is initiated. Trainees are expected to participate in a formal predoctoral curriculum offering broad and fundamental training in the neurosciences. We encourage a curriculum that spans the breadth of neurosciences in terms of the level of analysis (genes to molecules to cells to integrated, functional systems), approaches (including translational research), and the neuroscience of disease and disorders. Such training is expected to include core coursework, laboratory rotations, and programmatic activities, but not full-time thesis research. The training program should expose trainees to the clinical concepts relevant to their fundamental training in the neurosciences. This exposure, for example, may include seminars, coursework, or laboratory rotations in translational research. Programmatic activities unique to this training program are formalized interactions of participating departments and programs that may include, but are not restricted to, journal clubs, seminar series, and an annual retreat.

Institutions that presently have multiple training grants supporting early predoctoral trainees in the neurosciences are strongly encouraged to consolidate their predoctoral training positions into a single training grant jointly sponsored by the NIH Institutes participating in this funding opportunity. All applications must describe a plan to consolidate neuroscience training positions from existing predoctoral training grants supported by the NIH Institutes participating in this program announcement. All relevant training grants should be considered for consolidation, and some rationale must be presented if particular training grants will not be included in the consolidation plan.

Applications are also accepted from institutions that do not have current NIH training grant support and that provide neuroscience training.

The number of trainee positions requested must be justified in terms of the available pool of eligible trainees, the training faculty, the training track record, the training program, and the proposed consolidation of existing training positions, if relevant. The number of trainees suggested by the study section is considered the ceiling and may be decreased by NIH program staff based on availability of funds, track record for filling positions as assessed by annual progress reports and statements of appointment, and the overall needs of the Jointly Sponsored NIH Predoctoral Training Program in the Neurosciences.

When an extant Jointly Sponsored NIH Predoctoral Training Program in the Neurosciences submits a competing continuation application, the program must include the following information about former trainees in the Progress Report: 1) federal funding sources for the support of dissertation research; b) name(s) of dissertation advisor(s)/mentor(s); c) title of dissertation; and d) current position and institution.

2. Institutional Commitment: The administration of the applicant institution as well as all participating units and departments should indicate, in the application, their support for the goals of the training program. Describe support (financial or otherwise) that the institution will provide for the proposed training program. This could include, for example, space, shared laboratory facilities and equipment, funds for curriculum development, release time for the Program Director or participating faculty, support for additional trainees in the program, or any other creative mechanisms to improve the climate for the establishment and growth of the training program.

3. Evaluation and Tracking Component: The application must describe a strong evaluation and tracking component that will review the effectiveness of all aspects of the program (including curriculum, training faculty, training program director) and a system for tracking trainees for a 10-year period following program completion to determine program outcomes. Provide plans for monitoring trainee progress and overall program evaluation. Describe the measures (e.g., publications, grant proposals and awards, career trajectory of trainees) that will be used to assess the success or failure of the program. Outcome measures may include relevant positions obtained, current research activities, publication record, and the success rate of applying for and obtaining Federal and non-Federal research grant support. Data for tracking should include annual application, enrollment and appointment information. While the Program Director and Advisory Committee (if present) will of necessity help provide information for evaluation and tracking, the application should provide a prospective evaluation plan for process and outcome measures. The evaluation report should be included as part of the Progress Report at the time the competing continuation is submitted or as part of the Final Report if no competing continuation is submitted.

4. 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 (see http://grants.nih.gov/grants/guide/notice-files/not93-188.html). In addition, all competing continuation applications must include a report on the recruitment and retention of underrepresented minorities during the previous award period. If an application is received without a plan or without a report on the previous award period (if appropriate), the application will be considered incomplete and will be returned to the applicant without review.

Section V. Application Review Information

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

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

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

The following will be considered in making funding decisions:

The goals of NIH-supported research training and career development programs are to help ensure that a diverse pool of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation's biomedical, behavioral, and clinical research needs. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research training will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. Reviewers will first determine the quality of the training program and then consider whether the requested number of trainee positions is appropriate for the number of high-quality, eligible first/second-year trainees likely to be accepted in the program.

Training Program: This criterion assesses the objectives, design and direction of the training program. Does the proposed training program provide broad-based, fundamental, early-stage training in the neurosciences? Are appropriate courses available to provide a curriculum that spans the breadth of neurosciences in terms of the level of analysis (genes to molecules to cells to integrated, functional systems), approaches (including translational research), and the neuroscience of disease and disorders? Are appropriate programmatic activities incorporated into the training program?

Training Program Director: Does the Program Director have the scientific background, expertise, and experience or potential to coordinate and supervise a broad-based neurosciences training program? Has the Program Director committed adequate time to program administration?

Preceptors: Is there appropriate expertise available in the neuroscience community at the institution? What is the caliber of the preceptors as researchers, including the overall quality of their research, their publication record, and their successful competition for research support in areas directly related to the proposed training program? What is the record of the preceptors as mentors, especially as mentors of predoctoral students?

Institutional Training Environment: Does the environment in which the training program will be conducted, i.e. the quality of the participating departments and the extent of their participation, contribute to the probability of success? Does the training program represent the breadth of the neuroscience community at the institution? Is there evidence of adequate institutional commitment? Is there evidence of ongoing neurosciences research in areas relevant to the mission of one or more participating NIH Institutes? Is there evidence of adequate research support, equipment, and facilities?

Training Record: This criterion evaluates the past research training record of both the program and the designated preceptors. What is the success of former trainees in seeking further career development and in establishing productive scientific careers? Evidence of further career development can include successful completion of the PhD, receipt of fellowships or career awards, additional 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. What is the track record of the preceptors in directing predoctoral training or the potential of those preceptors lacking a track record?

Applicant Recruitment, Selection and Retention: What is the quality and size of the applicant pool? Are the recruiting procedures, trainee selection criteria, and retention strategies appropriate and well defined? Is the racial and ethnic diversity of the trainee pool in keeping with the availability of individuals from underrepresented groups within the relevant pool of applicants (see Special Programmatic Requirements in Section IV.6.)? For competing renewal applications, the success of efforts to recruit and retain minority trainees is a factor in the assessment of the quality of the applicant pool and will thus be included in determining the priority score.

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.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget. Is the requested number of trainee positions appropriate for the number of high-quality, eligible first/second-year trainees likely to be accepted into the training program? Can the number of positions be accommodated by the program given the availability of preceptors, their funding, and the number of trainees already in the program?

Evaluation and Tracking Plan: The application must describe a prospective evaluation and tracking plan (see Special Programmatic Requirements in Section IV.6.). Is this plan adequate to help ensure the effectiveness of the training program? NIH initial review groups will assess the applicant's plan based on the adequacy of plans for monitoring trainee progress, process and outcome measures, and overall program evaluation. The plan will be discussed after the overall determination of merit, so that the review panel's evaluation of the plan will not be a factor in the determination of the priority score. The plan will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note of the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised acceptable plan. Staff in the NIH awarding component will judge the acceptability of the revised plan.

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 (see http://grants.nih.gov/grants/guide/notice-files/not92-236.html). Applications must describe a program to provide formal and informal instruction on scientific integrity and ethical principles in research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will be returned to the applicant without review.

NIH initial review groups will assess the applicant's plan on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction. The initial review groups will also evaluate the results of assessments of this instructional program, if available. The plan will be discussed after the overall determination of merit, so that the review panel's evaluation of the plan will not be a factor in the determination of the priority score. The plan will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note of the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised acceptable plan. Staff in the NIH awarding component will judge the acceptability of the revised plan.

Minority Recruitment and Retention Plan: All competing applications for institutional NRSA research training grants must include a specific plan to recruit and retain underrepresented minorities in the training program (see http://grants.nih.gov/grants/guide/notice-files/not93-188.html). The success of efforts to recruit and retain minority trainees is a factor in the assessment of the quality of the trainee pool and thus will be included in the priority score. In addition, peer reviewers will separately evaluate the minority recruitment and retention plan and report (for competing continuation applications) after the overall determination of merit, so that the review panel's evaluation of this plan will not be a factor in the determination of the priority score. Here reviewers will assess the strategies to be used in the recruitment and retention of minorities. For competing continuation applications, reviewers will also assess whether the experience in recruitment during the previous award period has been incorporated into the plan formulated for the next award period. The plan will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note in the summary statement. Regardless of the priority score, applications with an unacceptable plan will not be funded until the applicant provides an acceptable revised plan. Staff in the NIH awarding component will judge the acceptability of the revised plan.

Consolidation Plan: Consolidation of NIH-funded predoctoral training in the neurosciences at an institution into a single training grant is strongly encouraged. A consolidation plan for combining training positions (or a justification not to consolidate) from other NIH-funded neuroscience-related training grants at the institution into a single training grant should be fully explained in the application. If consolidation is not proposed, the applicant should justify this plan. The consolidation plan and justification will be considered in relation to the participation of other departments in the training program. This information will not be factored into the numerical score but will be evaluated by the reviewers and considered in the budget recommendation.

2.C. Sharing Research Data
Not applicable.

2.D. Sharing Research Resources
Not applicable.

3. Anticipated Announcement and Award Dates
Not applicable.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

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 Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA 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.

NGAs are sent electronically to the office of the Administrative Official named in item 12 on the Face Page of the PHS 398 (rev. 09/2004) application form.

2. Administrative and National Policy Requirements

Institutional training grants must be administered in accordance with the current NRSA section of the Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm#_Toc54600204, and any terms and conditions specified on the notice of grant award.

Leave Policies: In general, trainees may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Trainees may receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Trainees may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the program director. A period of terminal leave is not permitted, and payment may not be made from traineeship funds for leave not taken. Trainees requiring periods of time away from their research training experience longer than specified here must seek approval from the NIH awarding component for an unpaid leave of absence. Trainees supported by academic institutions should refer to the NIH Institutional NRSA training grant guidelines at: http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html for further guidance regarding vacations and requested leave.

Part-time Training: While NRSA awardees are required to pursue research training full time, devoting at least 40 hours per week to the training program, under unusual and pressing personal circumstances, a trainee may submit a written request to the awarding component to permit less than full-time training. Such requests will be considered on a case-by-case basis. They must be approved by the awarding NIH Institute or Center in advance for each budget period. The nature of the circumstances requiring the 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 trainee must submit a written request countersigned by the Program Director 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 proposed research training program. In no case will it be permissible for the trainee to be engaged in Kirschstein-NRSA supported research training for less than 50 percent effort. Individuals who must reduce their commitment to less than 50 percent effort must take a leave-of-absence from Kirschstein-NRSA fellowship support. The stipend must be pro-rated during the period of any approved part-time training.

Carryover of Unobligated Balances: The carryover of funds from one budget period to the next requires prior written approval by the NIH funding component.

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 Program: Awards are made to a specific institution for a specific program under the guidance and leadership of a particular training Program Director. A change in any of these parameters requires prior approval the trans-NIH Jointly Sponsored T32 Training Committee. Any request for such changes must be submitted in writing, countersigned by the appropriate institutional business official, to the Program Officer specified in the Notice of Grant Award. A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program. Programmatic changes will be evaluated by the trans-NIH T32 Jointly Sponsored Training Committee to ensure that the program remains within the scope of the original, peer-reviewed application. If the new program does not satisfy this requirement, the award will be terminated.

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 Training Program Director (TPD): If change of a TPD is necessary, support of the award is not automatic but may be continued with prior written approval by the trans-NIH Jointly Sponsored T32 Training Committee, provided that the following conditions are met. The current TPD or the awardee institution has submitted a written request for the change, countersigned by the appropriate institutional business official, to the Program Officer specified in the Notice of Grant Award 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.

Other important information items regarding terms and conditions are located in the NRSA Guidelines found within the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm#_Toc54600187).

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.

The NRSA instructions for the Non-Competing Grant Progress Report (Form 2590) should be followed. The non-competing budget page should list the names and levels of those trainees who are continuing in the research training program. Information on each trainee should also be included in the narrative portion of the progress report as described in the PHS Form 2590 instructions. This NRSA program is not subject to SNAP.

Trainee Reporting Requirements: The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant. This Form must be completed at the beginning of the initial appointment and annually thereafter. No funds may be provided until this document is 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. 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.

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. There is no service payback obligation for current predoctoral trainees.

Final Reports: A final Progress Report and Financial Status Report are required at the end of the grant project period or upon relinquishment of an award.

Evaluation: In carrying out its stewardship of human resource-related programs, the trans-NIH Jointly Sponsored T32 Training Committee may request information essential to an assessment of the effectiveness of this Program. Accordingly, award recipients are hereby notified that they may be contacted during and after completion of this award for periodic updates on the trainees supported by this Program including various aspects of their employment history, publications, support from research grants or contracts, honors or 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 Jointly Sponsored NIH Predoctoral Training Program in the Neurosciences." Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.

Inventions and Patents: Traineeships made primarily for educational purposes are exempted from the PHS invention reporting requirements nor does NIH have any rights to inventions under these grants.

Copyright: 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.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Bradley C. Wise, Ph.D.
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
Gateway Building, Suite 350
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Telephone: (301) 496-9350
FAX: (301) 496-1494
Email: wiseb@nia.nih.gov

Antonio Noronha, Ph.D.
Division of Neuroscience and Behavior
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-7722
FAX: (301) 443-1650
Email: anoronha@mail.nih.gov

Deborah B. Henken, Ph.D.
Developmental Biology, Genetics and Teratology Branch 
National Institute of Child Health and Human Development
Executive Building, Room 4B01
6100 Executive Boulevard
Bethesda, MD 20892-7510
Telephone: (301) 496-5541
FAX: (301) 480-0303
Email: dh50g@nih.gov

Daniel A. Sklare, Ph.D.
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400C
6120 Executive Boulevard
Bethesda, MD 20892-7180
Telephone: (301) 496-1804
FAX: (301) 402-6251
Email: sklared@nidcd.nih.gov

Mimi M. Ghim, Ph.D.
Office of Science Policy and Communications, NIDA
6001 Executive Blvd., Suite 5230,
MSC 9591
Bethesda, MD 20892
Telephone: (301) 443-6071
FAX: (301) 480-2485
E-mail: ghimm@mail.nih.gov

Chyren Hunter, Ph.D.
National Eye Institute
Room 1300, MSC 9300
5635 Fishers Lane
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
FAX: (301) 402-0528
Email: clh@nei.nih.gov

Alison Cole, Ph.D.
Division of Pharmacology, Physiology, and Biological Chemistry
National Institute of General Medical Sciences
45 Center Drive, Room 2AS-49K, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3349
FAX: (301) 480-2802
Email: colea@nigms.nih.gov

Nancy L Desmond, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
Room 7197, MSC 9645
6001 Executive Boulevard
Bethesda, MD 20892-9645 (Rockville, MD 20852 for express/courier service)
Telephone: (301) 443-3563
FAX: (301) 443-4186
Email: ndesmond@nih.gov

NINDS Training and Career Development Officer
National Institute of Neurological Disorders and Stroke
Room 2154, MSC 9531
6001 Executive Boulevard
Bethesda, MD 20892-9531 (Rockville, MD 20852 for express/courier service)
Phone: (301) 496-4188
FAX: (301) 594-5929
Email: NINDSTrainingOffice@ninds.nih.gov

Mary Frances Picciano, Ph.D.
Office of Dietary Supplements
National Institutes of Health
6100 Executive Blvd. 3B01
Bethesda, MD 20892-7517
Phone: (301) 435-3608
FAX: (301) 480-1845
Email: PiccianM@mail.nih.gov

2. Peer Review Contacts:

Review Chief
Division of Extramural Activities
National Institute of Mental Health
6101 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892
Telephone: (301) 443-3367
FAX: (301) 443-4720

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Room 3201, MSC 9529
6001 Executive Boulevard
Bethesda, MD 20892-9529 (Rockville, MD 20852 for express/courier service)
Telephone: (301) 496-9223
FAX: (301) 402-0182
Email: nindsreview.nih.gov@mail.nih.gov

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

3. Financial or Grants Management Contacts:

Traci Lafferty
Grants and Contracts Management Office
National Institute on Aging
Gateway Building, Suite 2N212
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: laffertt@nia.nih.gov

Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
Email: jfox@mail.nih.gov

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

Christopher Myers
Grants Management Branch
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400B
6120 Executive Boulevard
Bethesda , MD 20892-7180
Telephone: (301) 402-0909
FAX: (301) 402-1758
Email: myersc@mail.nih.gov

Yinka Abu
Grants Management Branch
National Institute on Drug Abuse
6101 Executive Blvd, Suite 270, MSC 8403
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
Fax: (301) 594-6849
Email: abuy@mail.nih.gov

William Darby
Division of Extramural Research
National Eye Institute
Room 1300, MSC 9300
5635 Fishers Lane
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
FAX: (301) 496-9997
Email: wwd@nei.nih.gov

Toni Holland
Grants Management Officer
National Institute of General Medical Sciences
45 Center Drive, Room 2AN-50B, MCS 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-5132
FAX: (301) 480-2554
E-mail: hollanda@nigms.nih.gov

Rebecca D. Claycamp, CRA
Division of Extramural Activities
National Institute of Mental Health
Room 6122, MSC 9605
6001 Executive Boulevard
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
FAX: (301) 443-6885
Email: rc253d@nih.gov

Chris Zimmerman
Grants Management Specialist
National Institute of Neurological Disorders and Stroke
Room 3270, MSC 9537
6001 Executive Boulevard
Bethesda, MD 20892-9537
Telephone: (301) 496-3107
FAX: (301) 402-0219
Email: ZimmermC@ninds.nih.gov

Section VIII. Other Information

Required Federal Citations

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

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

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.

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

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

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

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

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

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
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Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


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