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
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 Environmental Health Sciences (NIEHS), (http://www.niehs.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/)

Title: Course Development in the Neurobiology of Disease

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-MH-05-011

Catalog of Federal Domestic Assistance Number(s)
93.213, 93.389, 93.867, 93.866, 93.273, 93.286, 93.865, 93.173, 93.121, 93.279, 93.894, 93.859, 93.242, 93.853, 93.361

Key Dates
Release Date: March 23, 2005
Letters of Intent Receipt Date(s): April 25 2005
Application Receipt Dates(s): May 25, 2005
Peer Review Date(s): July 2005
Council Review Date(s): August/September 2005
Earliest Anticipated Start Date: September 29, 2005
Additional Information To Be Available Date (Url Activation Date): n/a
Expiration Date: May 26, 2005

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

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 help to maintain a healthy nervous system throughout life. 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.

One of the great challenges in the coming decade will be to translate discoveries from molecular, cellular, and systems neuroscience into diagnostic tests, biomarkers, and strategies for prevention and treatment of diseases and disorders of the nervous system. Translating basic science discoveries into clinical benefit would be significantly enhanced if bench scientists (primarily PhDs) were informed about the biology and clinical presentation/course of neurological disease and became engaged in addressing these challenges through their research. Integrating courses on the neurobiology of disease into basic neuroscience training programs throughout the nation would help to forge important links between basic and clinical science. Although some neuroscience graduate programs offer a course on the neurobiology of disease, many of these courses are focused on specific diseases or are not a required part of the curriculum. Moreover, only a fraction of graduate students and postdoctoral fellows training in basic neuroscience participate in these courses. Recent findings make clear that similar fundamental biological mechanisms, and their dysfunction, are likely to underlie a variety of nervous system disorders. The state of the science is favorable to make conceptual connections between basic and clinical neuroscience, an important goal of the collaborative and coordinated NIH Neuroscience Blueprint. The Neuroscience Blueprint will support, through this funding opportunity, the development of new courses on the basic neurobiology of disease as well as the substantial expansion of existing courses on this topic.

Aberrations of normal structure and function as manifest in disease states can provide remarkable insight into cellular function and tissue system dynamics. Exposure to pathobiology is likely to broaden basic neuroscientists' interest in the disease states related to their basic research and thus increase the cadre of neuroscientists who contribute to the translation of basic science discoveries into clinical benefit. In addition, neuroscientists would benefit from exposure to different perspectives and multifaceted approaches to research questions that share a common theme, e.g., neurodegeneration. The Neuroscience Blueprint encourages the development of courses that:

The purpose of this funding opportunity is thus three-fold: (1) to stimulate the development of broad courses on the neurobiology of disease at academic institutions that train basic neuroscientists; (2) to encourage the integration of these courses into the neuroscience curricula throughout the home institution; and (3) to encourage course dissemination to the neuroscience community at large. The primary goal of this RFA is to foster course development at institutions where such an offering does not exist. For institutions developing a course on the neurobiology of disease de novo, it is expected that, at minimum, a course syllabus will be fully developed in year 1 and the course will be offered in year 2 of the award. A secondary goal of this RFA is to enhance existing courses on the neurobiology of disease by expanding and/or enhancing them substantially beyond the current course offerings.

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 Research Education (R25) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget 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.

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.

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.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

Foreign institutions are not eligible to apply.

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 graduate training programs in the neurosciences. The applicant institution must also have an active Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grant (T32) focused on basic neuroscience training that has a predoctoral component and that was awarded by one of the 15 NIH Institutes and Centers participating in the Neuroscience Blueprint. Moreover, there must be a minimum of one full year remaining on the qualifying T32 on September 30, 2005. This one-year period may reflect either the current performance period of the eligible T32 or the performance period of a competing T32 application pending award at the time of application in response to this RFA. It may not reflect a period of no-cost extension. T32s with only a postdoctoral component do not confer eligibility. T32 program directors are encouraged to contact their NIH program officer to verify that their T32 confers eligibility to apply for this funding opportunity.

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 Principal Investigator will be responsible for planning, directing, and executing the proposed course. This individual 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 development and implementation of the proposed course. The PI need not be the program director of the T32 that confers eligibility to apply for this funding opportunity. However, if not the director of the qualifying T32, the PI is expected to work with the director of neuroscience-focused T32(s) to ensure that this course will be available to trainees on the T32 and to others (basic science and clinical postdoctoral trainees and junior faculty) who would benefit from such a course.

A faculty team, in which the PI is a basic neuroscientist and the co-investigator is a clinician, may facilitate the development of the proposed course and help increase involvement of both basic and clinical scientists in this effort. The PI is expected to have a track record in graduate neuroscience education, e.g., as the director of a graduate neuroscience program or as a T32 program director. The co-investigator may be a clinician or, ideally, a clinician-scientist who actively participates in educational activities. These two investigators together are likely to provide the breadth of expertise and leadership needed to develop and implement the proposed course. Each of these two investigators must be willing to commit a minimum of 5% of their full-time professional effort to course development and implementation for the period of the award.

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 funding opportunity. Multiple applications from different divisions, faculties, schools, centers, etc. at the same institution will not be reviewed.

The applicant institution must also have an institutional training grant (T32) focused on basic neuroscience training that has a predoctoral component and that was awarded by one of the 15 NIH Institutes and Centers participating in the Neuroscience Blueprint. Moreover, there must be a minimum of one full year remaining on this T32 on September 30, 2005. This one-year period may reflect either the current performance period of the eligible T32 or the performance period of a competing T32 application pending award. It may not reflect a period of no-cost extension. T32s with only a postdoctoral component do not confer eligibility. An application submitted by an institution that lacks an institutional training grant meeting these criteria will not be reviewed.

The Research Plan section of the application may not exceed 15 pages in length. Applications exceeding this length will not be reviewed.

Applications lacking a dissemination plan or an evaluation plan will not be reviewed.

Section IV. Application and Submission Information

1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

The title and number 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.

The Research Plan section of the application may not exceed 15 pages in length.

Course Development and Implementation Plan: The Principal Investigator and his or her team is expected to develop a course on the neurobiology of disease at the graduate level that will be integrated into all basic neuroscience curricula at the academic institution. It may be appropriate to assemble an advisory committee, representing the participating basic and clinical disciplines, as well as the participating departments and programs, to assist in developing and implementing the course and to monitor its effectiveness. Basic and clinical neuroscience faculty from multiple programs, departments, and schools (if applicable) are expected to contribute to course development and implementation.

As background to the proposed course development and implementation plan, the Principal Investigator should describe the organization of graduate neuroscience education and the existing neuroscience curricula at the institution. Other sources of support for neuroscience training and education at the institution should be listed in table form. This information will provide a context for the proposed course.

In the case where an existing course on the neurobiology of disease will be expanded or otherwise substantially improved, details about the existing course (e.g., course format and frequency, topics covered, student pool, and evaluative feedback) should be provided. The intent of this RFA is not to eliminate any consideration of the neurobiology of disease from specialized courses in the graduate neuroscience curriculum at an institution. Rather the intent is to encourage the development of a comprehensive course on this topic. This course could be one of several initiatives or activities at the institution to promote training on the neurobiology of disease, e.g., seminars, journal clubs, symposia, etc.

Although R25 education grants are not typical research instruments, they do involve experiments in education that require an evaluation plan in order to determine the degree of success or failure. A plan must be provided for the evaluation of the course on the neurobiology of disease. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report outcome measures that would determine the success of the research education program in achieving its objectives.

A specific plan must be provided to disseminate the course and any course materials nationally, e.g., Web postings, presentations at scientific meetings, workshops, etc.

Allowable Costs: Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the course development proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution.

Up to five percent of each of the PI and a co-investigator's base salary (to the NIH annual base salary cap, currently $180,100) may be requested. The total salary requested must be based on the investigator's full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff of equivalent qualifications, rank, and responsibilities in the department concerned. The actual salary and fringe benefit rate for each investigator should be provided. Salaries requested may not exceed levels commensurate with the applicant institution's policy for those in similar positions.

Limited administrative and clerical salary costs associated specifically with the education program, that are not normally provided by the applicant institution, may be direct charges to the grant only if they are specifically identified and justified. Consultant costs, equipment, supplies, travel, and other program-related expenses must be justified as specifically required by the proposed education program and must not duplicate items generally available for educational programs at the applicant institution.

Recognizing that course expansion and/or enhancement is likely to require less time and funds than de novo course development, institutions proposing to expand an existing course should especially carefully justify the requested award duration and budget.

Evidence of institutional commitment to the educational program is strongly encouraged.

Facilities and Administrative (F&A) Costs: F&A costs will be reimbursed at 8 percent of modified total direct costs, or at the actual indirect cost rate, whichever is less.

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

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: April 25, 2005
Application Receipt Date(s): May 25, 2005
Peer Review Date: July 2005
Council Review Date: August-September 2005
Earliest Anticipated Start Date: September 29, 2005

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:

Nancy L Desmond, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7197, MSC 9645
Bethesda, MD 20892-9645 (Rockville, MD 20852 for express/courier service)
Telephone: (301) 443-3563
FAX: (301) 443-1731
Email: ndesmond@mail.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 three signed photocopies in one package to:

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

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

Jean G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609 (Rockville, MD 20852 for express/courier service)
Telephone: (301) 443-3367
FAX: (301) 443-4720
Email: jnoronha@mail.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. Personal deliveries of applications are no longer permitted.

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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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).

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

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

6. Other Submission Requirements

Supplementary Application Instructions

1. Application face page: Item number 2 on this page must list this RFA number and its title, Course Development on the Neurobiology of Disease.

2. Description, Performance Sites, and Key Personnel (Form Page 2): In the Description, specify the T32 award (grant number and PI) that confers eligibility to apply for this funding opportunity. Under Performance Sites, include Consortium/Contractual Arrangements, and a list of collaborating sites, if appropriate. If multiple sites are to be used, the applicant institution must be one of those sites. A justification must be included if any other sites will be used. Key Personnel should include the principal investigator, other key faculty participating in course development (e.g., co-investigator and/or advisory committee members), as well as any staff integral to course development.

3. The application, and thus the table of contents, should be organized as follows:

4. Detailed Budget for the First Year (Form Page 4): Under Personnel, list each individual for whom support is requested with his/her percent effort, salary and fringe benefits.

5. Budget for the Entire Proposed Project Period of Support (Form Page 5): Provide projected future year budget as instructed in the PHS 398 and a detailed budget justification for all items requested. Provide the academic institution's current fringe benefit rate.

6. Resources (Resources Format Page): Describe the educational environment including a list of participating departments, facilities, laboratories, computer services, and any other resources to be used in the development and implementation of the proposed course. Describe how these facilities will be available to the proposed education program. List all sources of support for graduate training and education in basic neuroscience following the format for Other Support described in the PHS 398. Use continuation pages as necessary.

7. Research Plan: This section should be re-titled Course Development in the Neurobiology of Disease and should contain material organized under the following subheadings, as appropriate for the specific program.

a) Specific Aims.

b) Background: Provide an overview of the existing graduate neuroscience training program(s) at the institution. If multiple programs exist, describe all of them. List the requirements for each graduate training program (required courses, rotations, and programmatic activities such as seminars, journal clubs, and retreats) and any other venues where graduate students are exposed to the neurobiology of disease. Make reference to the available support for graduate neuroscience training listed under Resources.

c) Proposed Course Development and Implementation Plan: Provide programmatic detail on the proposed course, including its format (e.g., lecture, small group discussions, student presentations, patient presentations/interviews) and frequency, topics to be covered, student pool, and a description of plans to educate students regarding ethical issues in clinical research. Explain how this course fits into the institutional plans and goals for neuroscience training and how it will be integrated into the existing neuroscience training programs. A plan for periodic updating of the course beyond the two-year project period should be described. If the proposal extends an existing course on the neurobiology of disease, highlight the innovative and novel components that will be added to the course.

d) Course Administration and Participating Faculty: Describe arrangements for course administration. Describe the PI's commitment to developing and implementing a course on the neurobiology of disease in the graduate neuroscience curricula at his/her academic institution. Provide evidence that the Principal Investigator and his/her team is actively engaged in research and teaching of neuroscience and that they have the requisite skills to organize and administer a course that is based on sound research concepts and educational principles. Provide evidence of broad institutional collaboration in course development and implementation. Describe the participating faculty, including evidence that both basic and clinical neuroscientists from multiple programs, departments, and schools (if applicable) at the participating institution(s) are participating.

e) Environment and Institutional Commitment: The institution must provide evidence of commitment to and support for the proposed course development and implementation including a commitment to integrate the course into existing neuroscience curricula at the institution, and to periodically update the course beyond the project period.

f) Evaluation Plan: Include evaluation plans for determining the success of the course in meeting its goals and objectives. Describe the information that will be collected and evaluative criteria to be used. The inclusion of evaluation instruments is encouraged.

g) Dissemination Plan: Provide a plan for the dissemination of course materials to other academic institutions nationally, e.g., using Web postings, presentations at meetings and workshops, etc.

8. Facilities and Administrative (F&A) Costs, formerly known as indirect costs, will be reimbursed at a rate of 8% of modified total direct costs for the applicant organization and any approved subcontract, or at the actual indirect cost rate, whichever is less. Funds for the evaluation plan are not expected to exceed 5% of the total direct cost.

Plan for Sharing Research Data
Not applicable

Sharing Research Resources
Not applicable. However, a dissemination plan is a required component.

Section V. Application Review Information


1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the Blueprint Neurobiology of Disease Project Team . Incomplete and/or non-responsive applications will not be reviewed.

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

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

The goals of NIH supported research training, education, and career development programs are to help ensure that a diverse pool of highly trained scientists are available in adequate numbers and in appropriate scientific areas to address the Nation's biomedical, behavioral, and clinical research needs. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research education program will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major impact and thus merit a high priority score. These criteria are not listed in their order of priority.

Course Development Plan

Principal Investigator and Course Team

Institutional Commitment and Resources

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 plan. Are appropriate justifications provided for each budgeted item? If more than 5% of the total direct cost is requested for the evaluation plan, is an appropriate justification provided? The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data
Not applicable

2.D. Sharing Research Resources
Not applicable

3. Anticipated Announcement and Award Dates
Anticipated Award Date: September 29, 2005

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will 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.

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. If a grantee is not e-mail enabled, a hard copy of the NGA 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 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.

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 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).

Change of Institution: The Blueprint for Neuroscience Research Education Project Grant cannot be transferred from one institution to another.

2.A. Cooperative Agreement Terms and Conditions of Award
Not applicable

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 Progress Report should provide information on the development and implementation of the course, modifications to the research education program as originally proposed, the number of graduate students and postdoctoral fellows participating in the course during its implementation phase, updates on the evaluation of the research education program, and dissemination activities.

Evaluation: In carrying out its stewardship of human resource-related programs, the Neuroscience Blueprint 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 various aspects of course development, implementation, dissemination, and other information helpful in evaluating the impact of this program.

Publication and Sharing of Research Results: Investigators are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from this award, 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.

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:

Nancy L Desmond, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7197, MSC 9645
Bethesda, MD 20892-9645 (Rockville, MD 20852 for express/courier service)
Telephone: (301) 443-3563
FAX: (301) 443-1731
Email: ndesmond@mail.nih.gov

2. Peer Review Contacts:

Review Chief
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda , MD 20892-9609
Telephone: (301) 443-3367
FAX: (301) 443-4720

3. Financial or Grants Management Contacts:

Dawn Walker
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6118, MSC 9605
Bethesda , MD 20892-9605
Telephone: (301) 443-3858
FAX: (301) 443-6885
Email: walkerde@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

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

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

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

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.

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 Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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


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