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Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
National Human Genome Research Institute (NHGRI) (http://www.nhgri.nih.gov)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)

Title: Centers of Excellence in Genomics Science (CEGS) (P50)

Announcement Type
This is a reissue of PAR-05-163.

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

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-08-094

Catalog of Federal Domestic Assistance Number(s)
93.172, 93.242

Key Dates
Release Date: February 22, 2008
Letters of Intent Receipt Date(s): April 25, 2008; April 25, 2009; April 25, 2010
Application Receipt Date(s): May 25, 2008; May 25, 2009; May 25, 2010
Peer Review Date(s): October-November 2009, 2010, 2011
Council Review Date(s): January 2009, 2010, 2011
Earliest Anticipated Start Date: April 2009, 2010, 2011
Additional Information To Be Available Date (Url Activation Date): not applicable
Expiration Date: (New Expiration Date January 8, 2010 per NOT-OD-10-030), Old Date: May 26, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism 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 and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The Centers of Excellence in Genomic Science (CEGS) program establishes academic Centers for advanced genome research, using the P50 Specialized Center mechanism. Each CEGS grant supports a multi-investigator, interdisciplinary team to develop innovative genomic approaches to address a particular biological problem. A CEGS project will address a critical issue in genomic science, proposing a solution that would be a very substantial advance. To achieve such advances, the research conducted at these Centers will entail substantial risk, balanced by outstanding scientific and management plans and very high potential payoff. A CEGS will focus on the development of novel technological or computational methods for the production or analysis of comprehensive data sets, or on a particular genome-scale biological problem, or on other ways to develop and use genomic approaches for understanding biological systems. An extraordinary level of synergy, integration, and potential for advancement of genomics, is expected from each CEGS project; this mechanism will be used only for projects that could not be achieved by using other, more standard grants mechanisms. Exploiting its outstanding scientific plan and team, each CEGS will nurture genomic science at its institution by facilitating the interaction of investigators from different disciplines, and by providing training of new investigators, will expand the pool of professional genomics scientists and engineers.

Background

The initial goals of the Human Genome Project (HGP) were met with the completion of the mapping and sequencing of the human genome and the genomes of several important model organisms. The HGP and the related genomic research supported by NHGRI have been characterized by a focus on efficient data production, the development of new technologies, and large, comprehensive genomic data sets such as genomic maps and complete DNA sequences, catalogs of human DNA sequence variation (e.g., the HapMap project) and projects to annotate all of the functional elements of the human genome (ENCODE). Once the DNA sequence of an organism becomes available, many new avenues to studying its biology are opened. However, new and improved concept development, research tools, approaches, and capabilities are needed to discover and exploit the vast amount of biological information in complete genomic DNA sequences. Therefore, in 2000, NHGRI established the CEGS program, and was joined in 2001 by NIMH, to stimulate the development of such new approaches, which involved computational, instrumental, biochemical, genetic, and analytical technologies and conceptual frameworks. These approaches require the expertise of teams of investigators from different fields as well as substantial infrastructure. Some of the many important opportunities in genomics are described in A Vision of the Future of Genomics Research (Nature, 2003, 422:835) (available at http://www.genome.gov/11007524). Examples of projects that have been supported under the CEGS program to date can be found at http://www.genome.gov/10001771.

The CEGS program extends NHGRI's and NIMH’s research programs in new directions. While the Institutes continue to support research to generate comprehensive data sets, the purpose of the CEGS program is to provide support for the development of innovative, basic and potentially large-scale genomics research projects. The CEGS have explored ways to conduct biological research at a genomic scale and have developed new concepts, methods, approaches, tools, or technologies to make possible novel analyses of biological questions from a genomic perspective.

NHGRI and NIMH are committed to continuing to support basic genomic research through investigator-initiated, single-laboratory project grants, using the R01, R21 and other appropriate grant mechanisms, under existing and future programs. However, the resources needed to conduct the multi-faceted, multi-disciplinary projects that may be required to achieve significant advances for these complex problems are sometimes beyond the scope of the typical R01 grant. Therefore, the CEGS program presents an opportunity for applicants to assemble the teams of investigators from diverse disciplines that will be required to approach biological problems using genomics tools in ways that are not possible today. High priority will be given to projects that integrate multi-investigator, multi-disciplinary approaches to a focused scientific problem, especially those that can meld computational and experimental approaches.

Scope of Research

A CEGS will develop new approaches that will ultimately foster the integration of genomics with biomedical research. It will investigate novel ways to apply existing genomic-scale, comprehensive technologies to studying a biological problem, or develop new concepts, methods, technologies, or ways to analyze data, that will advance the state of the art in applying genomic approaches to biomedical studies. It must be tightly focused on a single biological problem or on an approach to solving biological problems, using genomic concepts and methods.

The research plan for a CEGS must encompass a very high level of innovation. The product of CEGS research is expected to dramatically enhance the biomedical research community's capabilities for conducting comprehensive, cost-effective, high-throughput biomedical studies related to the DNA sequence and sequence products of organisms, with particular focus on human biology and disease. A CEGS project is expected to lay out a specific and substantive product that can be identified as having been the outcome of CEGS funding. NHGRI will consider funding such an effort up to a maximum of ten years, but as the goal of the program is to stimulate rapid progress in genomics, NHGRI in interested in the product or its precursors (e.g., publications, data) becoming available to the community throughout the duration of the grant. In achieving that product, a CEGS has the obligation to take on challenging aspects of a problem, including ones that have slowed progress in the chosen area of research. Other investigators are likely to solve some of those problems during the ten-year duration of a CEGS; a CEGS should be sufficiently nimble as to be able to adopt those solutions, so that CEGS resources can continually be applied toward tackling the unsolved challenges.

Proposing to change the way genomic science will be done in the future entails a substantial level of risk because the research will, by definition, not be incremental. To balance this risk, the application must present a well developed scientific and management plan to achieve a high pay-off result. Collaborations to develop genomic approaches require proficiency in several disciplines; a CEGS proposal should engage the expertise of a multi-disciplinary team, drawing from specialists in a wide range of fields such as biology, genetics, clinical medicine, physical sciences, mathematics, computer science, and engineering, as appropriate for the project. The various components of the program must be synergistic and interdependent, not simply related; each component must produce results that are required for progress by the other components. Applications that employ state-of-the-art science that fill in knowledge but do not break substantially new ground are unresponsive to this solicitation.

This PAR does not provide a list of examples of possible Center themes because of the desire not to limit applicants' imaginations and to solicit truly new ideas for genomic approaches to biological problems, as they pertain to the goals discussed above. Investigators who wish to propose developing such novel approaches are strongly encouraged to discuss their ideas with program staff prior to submitting an application, to ensure that applications will be responsive to the CEGS program.

Biomedical research has entered an era in which the solutions to many important problems require the collection and analysis of large data sets, such as an entire genome, an entire set of expressed RNAs or proteins, an entire gene family from a large number of species, the variation within a population of a genomic region of substantial size, or a class of gene regulatory or chromatin organizational elements. Therefore, the unifying theme for this program will be that the Centers will address important biological problems on a "genomic scale." In this context, the term genomics is not limited to studies directly related to DNA sequence, but instead encompasses global, comprehensive, high-throughput, cost-effective approaches to studying biological systems, including for example DNA, RNA, proteins, metabolites, and regulatory and biochemical pathways and networks. Some projects may result in new analyses of existing data sets, while others may result in technologies and methods that provide the ability to collect, analyze, and present effectively new types of genomic data sets. The genomic approaches and technologies that are proposed to be developed under CEGS support should be applicable to a wide variety of cell types or organisms, and should be usable in a global, high-throughput, cost-effective manner. Methods and concepts that are applicable only to a particular genetic locus, disease, or organ system will not be supported under this program. Model systems, such as a limited number of gene families, regulatory networks, or pathways, may be used to develop the genomic approach, as long as the approach is scalable and broadly applicable. The grant application must clearly justify how the model study will be expandable beyond the particular model(s) used in the developmental research, to ultimately support global analyses. For example, if a particular pathway is being modeled, the application must explain how the modeling algorithms will be extended to other pathways. To the extent that cost-effective, global approaches can be developed and also applied within the context of the CEGS budget, such application of the new approach is acceptable. However, the budget limits under this PAR may preclude both developing and globally applying the genomic approach that is the subject of the research.

NIMH is especially interested in novel genomic approaches that have high potential for accelerating our understanding of the genetic basis of the nervous system and mental disorders. Thus, these systems may provide appropriate models for developing the genomic approach, as described above, and similarly, CEGS project outcomes are generally expected to advance these goals because of their broad applicability.

Cost and data quality are central issues in the development and application of genomic approaches. Therefore, each CEGS proposal must address these factors in the grant application and must implement those plans under CEGS support. Cost and quality concerns must be addressed both in terms of any utilization of conventional technologies for the collection of trial data sets within the CEGS research plan (if such data collection is required), and of the manner in which novel technologies and concepts generated by the CEGS would be applied in the future.

The cost of collecting global data sets is often very high; therefore, a CEGS application that aims to very significantly reduce the cost of collecting a data set that, today, can be collected only at great expense, could be substantially enabling to the genomics community, and is therefore considered responsive to this PAR.

It is anticipated that a CEGS may employ large amounts of data to accomplish its goals. However, the application of genomic technologies for data production per se is not the purpose of a CEGS, and the CEGS program is not intended primarily to build infrastructure for the application of current genomics technologies. Applicants may use data sets collected under other funding, if the CEGS project's purpose is to develop novel, integrated analyses that extend the interpretation and utility of those data. Decisions by NIH to embark on the large-scale implementation of any new tools developed by a CEGS to generate large data sets will require careful consideration, with advice from the scientific community.

Partnerships may consist of investigators at a single institution or at multiple different institutions (e.g., center-without-walls). As is true for any team that is being assembled for a CEGS project, the constitution of a geographically-distributed team must be well justified, and steps that are required to mitigate the effects of geography should be clearly stated. Involvement of private sector companies, while not required, is acceptable and may be included to the extent that expertise and resources needed for conducting and disseminating the results of CEGS research may reside outside of academia.

Leveraging of genomic resources: Preference will be given to the development of genomic methods for eukaryotes where genome sequence is available. Methods development or pilot studies using other systems (e.g., eukaryotes whose genomes have not been sequenced, or prokaryotes for which the genomic sequence is known) will be considered with adequate justification; direct applicability of methods and concepts developed in such a project to the analysis of eukaryotic genomes must be evident. Where appropriate, integration with other NIH genomics initiatives (e.g., NHLBI genomics program [http://www.nhlbi.nih.gov/resources/pga ], the Mammalian Gene Collection [http://mgc.nci.nih.gov], ENCODE (ENCyclopedia Of DNA Elements) [http://www.genome.gov/10005107] and SNPs/HapMap [http://www.genome.gov/10001688]) will be considered advantageous.

Training Objectives

A CEGS has two related training objectives. The first is the training of all Center-associated investigators, and the broader research community at the institution, in the development and use of genomics approaches to the study of biology and medicine. The second is the training of minorities who are underrepresented in genomics. Requirements for both are described in this section. The costs associated with the broader training goals are to be incorporated within the $2 million CEGS cost cap. Additional funds may be requested for the training of minority scientists, as further described below.

1. General Genomics Training Component

Each CEGS application is required to have a training component that leverages the strengths of the Center and its investigators to train the next generation of interdisciplinary scientists who will bring creativity to studying biological problems through a genomic approach. There is a widely recognized shortage of investigators who have the interdisciplinary skills needed to conduct most effectively the types of genome-scale research described in this PAR. One reason for the lack of adequately qualified personnel is that there are too few appropriate environments available to support this kind of training. The CEGS program is intended to help to alleviate this shortage by supporting the development of Centers that can serve as academic foci for genomics, and thereby to increase the cadre of investigators qualified to participate in the development of new genomics approaches to biomedical research. Therefore, a CEGS proposal must demonstrate that an effective program can be established at an institution that does not yet have substantive programs in genomics, or that a new program adds significant value to the genomics capabilities that exist at an institution in which genomics is already well established.

To maximize the impact of these Centers, they should integrate the training of new investigators and broaden the training of established investigators. This might include plans to recruit into genomics investigators who are already trained and accomplished in other fields of research and engineering. Graduate students and postdoctoral fellows, at a minimum, should participate in the research; however, such participation alone will be considered insufficient to meet the training goals of the CEGS program. NHGRI and NIMH expect applicants to develop creative approaches, using a combination of the standard training vehicles used by academic institutions (e.g., training grants, fellowships, research education programs, seminar programs, course work) and more novel avenues. This training program should take advantage of unique aspects of the research program, the combination of participating investigators' talents , and other unique institutional resources that underpin the CEGS, to offer innovative, substantive training opportunities for pre-doctoral students, post-doctoral fellows, and other investigators. The CEGS will therefore become an additional opportunity, beyond those previously developed by NHGRI and NIMH (see e.g., http://www.genome.gov/10000950 and http://www.nimh.nih.gov/researchfunding/training.cfm), for expanding the cadre of investigators working in the field of genomics.

2. Minority Action Plan

NHGRI and NIMH are committed to increasing the number of individuals from underrepresented minority groups who have the training to pursue careers in genome and ethical, legal and social implications (ELSI) research. Genome research offers tremendous challenges and opportunities for improving human health and ELSI research offers the chance to explore some of the most profound ethical, legal and social issues of our time. NHGRI and NIMH want the best minds to participate in this work. There are extraordinary career opportunities in genome and ELSI research in which all should share.

The very nature of genome and ELSI research demands the inclusion of a diversity of points of view and scientific interests. One of the major emphases of genomics is to investigate how DNA sequence variation affects phenotypic differences, especially differences in susceptibility to disease among various groups. The significant societal ramifications of this research will also need to be addressed. It is clearly desirable to have individuals involved who bring diverse perspectives to this research, including an interest in understanding diseases that disproportionately affect some populations. Genome research will affect all populations and thus all groups need to participate in setting the research agenda and examining the broader issues raised by it.

Unfortunately, despite a number of ongoing training and recruitment activities, success has been limited in attracting underrepresented minorities into genomics and ELSI research to date. To begin the process of addressing this issue, the NHGRI convened a meeting on April 16-17, 2001, to explore new and innovative ideas and models for increasing the number of underrepresented minorities pursuing research careers in genomics and related sciences. Subsequently, various programs have been funded, and these programs have been monitored and adjusted at least annually. A summary of the planning and currently-funded activities may be found at the Minority Action Plan portal (http://www.genome.gov/14514219), and information for applicants, including information related to the $300,000 direct cost limit for this activity, is available at http://www.genome.gov/10003996.

The scope and importance of research conducted in CEGS is anticipated to provide an outstanding opportunity for the training of underrepresented minority scientists. Moreover, the research infrastructure of CEGS institutions provides ideal training environments for short and long-term training opportunities. NHGRI and NIMH require all CEGS programs to include training of underrepresented minorities. Therefore, in addition to developing an overall training plan, applicants should describe their specific plans for training of underrepresented minorities.

Whereas training of underrepresented minorities at all career levels is appropriate, applicants are encouraged to establish programs that give priority to the undergraduate through professional career levels. These activities must be integrated in the ongoing research activities of the CEGS.

ELSI Objective

For CEGS research projects that raise substantial ethical, legal, or social concerns (e.g., the study of sequence variation in specific populations), a component of the Center focusing on analysis of such concerns as they relate to the particular research proposed is strongly encouraged. To be considered for funding as part of the CEGS grant, the ELSI research must be extensively and effectively integrated with and highly relevant to the research plan. Current information on the NHGRI ELSI program is available at http://www.genome.gov/10001618. Please note that CEGS applications are not required to have an ELSI component. Information pertaining to NHGRI's Centers of Excellence in ELSI Research (CEERS) program is available at http://www.genome.gov/15014773.

Renewals

Renewal grant applications are accepted in this program. The criteria for accepting renewals are essentially the same as for new applications. A key issue for evaluating renewals concerns the level of innovation that is expected. CEGS projects were originally envisioned as taking up to 10 years to complete. In most grant programs, a renewal application for a grant that is meeting its originally-proposed timeline would be considered successful. However, for a CEGS grant it is not sufficient to maintain course.

The field of genomics has seen remarkable advances since earlier CEGS grants were awarded. Projects seeking renewal must continue to propose to advance the state of the art of genomics and its applications to biomedicine, substantially beyond what exists at the time of the renewal application. Renewal applications, like new applications, should tackle the hardest problems in the area of their focus, because those are the problems that are impeding significant progress in biomedical research. Successful renewals will also have established a track record in genomics training in general and in their Minority Action Plan programs specifically; they will be held to a high standard for those essential CEGS components.

Budget Limits

The CEGS program, and projects that have been funded under this program, are extremely ambitious. Nevertheless, even for applications that receive outstanding priority scores, the budget will be scrutinized with care, and the award may not be for the full amount that the program allows applicants to request.

For example, activities that are related to, but not essential for the focal activities of that CEGS will be deleted at the time of award. Similarly, a project may not be funded for the full five years that applicants are permitted to request if, e.g., that duration of support is not deemed critical to achieving essential goals or if progress needs to be formally evaluated after fewer years. Funding decisions will also incorporate programmatic considerations of balance and the desire to initiate new, bold projects within the funds available to the program.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity announcement (FOA) will use the National Institutes of Health (NIH) P50 Specialized Center award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

2. Funds Available

NHGRI and NIMH anticipate supporting approximately ten CEGS P50 projects at any one time and therefore that one to four P50 awards will be made per year. Information on currently funded projects is available at http://www.genome.gov/10001771. 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. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received, and the existing investment in the program. Although the financial plans of NHGRI and NIMH 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. Competing renewal and new CEGS applications compete for the same funds. Awards will begin approximately nine months after the corresponding application receipt date.

Applicants may request up to $2 million direct costs for any year for continuing operations (e.g., personnel, standard laboratory equipment, supplies, travel, consortia, and other expenses). Inflationary adjustments above $2 million will not be allowed. Under this cap, it is anticipated that the size and duration of the awards will vary because the nature and scope of research programs will vary. Because of the unusual nature of these Centers, they may need to acquire specialized equipment. Funds for such specialized equipment may be requested in excess of the $2 million operating limit if well justified. Specialized equipment in excess of $500,000 over the life of the grant will generally not be permitted. The additional exception to the $2 million direct costs cap for general operating funds is support for the Minority Action Plan (see below, under Section IV. 6, entitled GUIDANCE FOR APPLICANTS FOR P50 CENTER GRANTS), which may request up to $300,000 direct costs annually (for details on the MAP budget, see http://www.genome.gov/10003996).

A P50 Center grant application may request up to five years of support. The length of award will be determined through the peer review and Council advisory processes. Genomics is a rapidly changing field, and it is anticipated that most projects that can be initiated now are likely to have a limited lifetime during which support as a CEGS will be appropriate, either because the project goals will have been accomplished or the Center will have developed to the point that support from another source will be more appropriate. Therefore, the total length of support for any P50 Center under this program will not exceed ten years.

In general, each CEGS will receive an administrative site visit during the third year of each competing cycle. The fifth year of funding will depend on the outcome of that administrative review, and the Principal Investigator (P.I.) will receive advice about the NIH’s interest in accepting a competing renewal application to extend the initial award.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Applications from foreign institutions and for-profit organizations will not be accepted; however, subcontracts to foreign institutions and for-profit organizations will be considered.

1.B. Eligible Individuals

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

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement. However, institutional commitment can substantially strengthen the ability to fulfill CEGS program goals, including both research and training. Any institutional commitment should be described in the section entitled Management and Organization.

3. Other-Special Eligibility Criteria

Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement).

Renewal (formerly competing continuation ) applications will be accepted; the total project period for a CEGS grant is not expected to exceed ten years.

An investigator may submit only one application per receipt date. An institution may submit more than one application but they must involve different investigators and different scientific topics.

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: [email protected].

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. 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 lines 1 and 2 of the face page of the application form and the YES box must be checked.

Foreign Organizations [Non-domestic (non-U.S.) Entity]

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

NOTE: Applications from foreign organizations are not allowed, but the following information is provided for foreign components of applications from U.S. institutions.

Applications from foreign organizations must:

In addition, for applications from foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date(s): April 25, 2008; April 25, 2009; April 25, 2010
Application Receipt Date(s): May 25, 2008; May 25, 2009; May 25, 2010
Peer Review Date(s): October-November 2009, 2010, 2011
Council Review Date(s): January 2009. 2010, 2011
Earliest Anticipated Start Date(s): April 2009, 2010, 2011

3.A.1. Letter of Intent

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

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 in Section IV.3.A.

Jeffery A. Schloss, Ph.D.
Division of Extramural Research
National Human Genome Research Institute, NIH
Phone: (301) 496-7531
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

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

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

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

Rudy Pozzatti, Ph.D
Scientific Review Branch
National Human Genome Research Institute, NIH
Suite 4076, MSC 9306
5635 Fishers Lane
Bethesda, MD 20892-9305 (U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service, non-USPS service)

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.

U pon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 renewal award if such costs: 1) are necessary to conduct the project, and 2) 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 renewal 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 and Information

Guidance for Applicants for CEGS P50 Center Grants

Innovative Genomic Approach

The applicant should identify clearly in the abstract and describe fully in the research plan (sections 2-5) the new capabilities that are proposed to be developed, and the specific biological context in which those capabilities will be developed and studied, as a result of the establishment of the Center. The synergies achieved through the establishment of multi-disciplinary teams and collaborations should also be fully described, as these are central requirements for the establishment of a CEGS. The Research Plan should also describe the experimental rationale and approach and its significance, timelines, contingencies, risky aspects of the research and how that risk will be mitigated, and all of the other aspects of the plan that respond to the characteristics of a CEGS as described in other sections of this solicitation.

In addition to the Research Plan, sections 2-5, each of the items listed here must be addressed in clearly labeled sections of the application: Human Subjects, Vertebrate Animals, Management and Organization, Training Plan, Minority Action Plan, ELSI Research Plan (if included), and Data and Materials Dissemination Plan. For page limits, see below.

Management and Organization

A successful P50 grant application will include a well-integrated project plan. The grant application should describe the specific administrative and organizational structure that will be used to support the research, and the synergies enabled by this structure. CEGS projects will be multi-disciplinary and will draw on a variety of resources. Thus, a well thought-out and carefully described organization will be required. Unlike many centers, most current CEGS projects do not use service cores. If core facilities or shared resources are required, these should be described, as should their management and service to the research projects.

The application should explain how different components of the organization, including key personnel, will interact, why they are essential to accomplishing the overall goal of the research, and how the combined resources create capabilities that are more than the sum of the parts. Clear evidence that the key investigators will collaborate effectively must be presented in the application. "Centers-without-walls" are welcome under this solicitation. However, if any component of a proposed Center is physically separated from the others (i.e., in a different department or institution), the application must address how the effects of that separation will be managed. The NIH is not specifying a particular organizational structure for a CEGS, as each applicant should develop the structure that would best promote the proposed research. However, the effectiveness of the proposed structure will be a criterion of the evaluation prior to an award and its implementation will be monitored after an award is made.

The P.I. is responsible for ensuring that scientific goals are met and for developing and managing a decision-making structure and process that will allow resources to be allocated (and reallocated, as necessary) to meet those goals. In addition to shifting resources among the existing CEGS partners, it may occur, as one set of problems is solved and others arise, that personnel with additional expertise would be needed. But, due to budget limits, that might require reducing or eliminating effort of previously-supported personnel. Working at the cutting edge on high-risk projects will require flexibility to accommodate emerging opportunities or to eliminate less productive branches of research. CEGS management must be designed to accommodate such flexibility.

To be successful, projects of the complexity, both scientific and managerial, that NHGRI and NIMH anticipate will characterize a CEGS require a substantial amount of the P.I.'s effort. Therefore, the P.I. will be required to devote at least 30% effort to the leadership and implementation of the Center.

A timeline for the project should be presented. This timeline should outline how the project's goals can be met within the time frame of a CEGS grant. The timeline will also assist the investigators, NHGRI and NIMH, and their advisors in evaluating progress toward the project's goals. For those projects for which the investigator deems it appropriate to do so, applicants are encouraged to present explicit, quantitative milestones.

The P.I. and other members of the research and training team will be expected to participate in grantee meetings, held approximately annually at grantee sites or near the NIH. Funds for travel of up to four people per grantee meeting may be included in the budget request. Grantees will be expected to host these meetings on a rotating basis, as determined by NIH staff.

Cost sharing or institutional support, if any, should be described in this section.

Training Plan

Referring to the training goals described above, this section of the application will describe the training plan, and how the proposed CEGS training component would broaden the expert base of genomics research scientists. Training of underrepresented minority individuals is a special priority and must be described in detail in a separate section immediately following the Training Plan, entitled Minority Action Plan. Instructions for preparing this component of the plan are available at http://www.genome.gov/10003996. Budget items to support the general training plan should be included in the budget for the scientific activities (i.e., it is included within the $2 million direct costs cap). A separate budget page should be prepared for the Minority Action Plan budget, as described at http://www.genome.gov/10003996.

Budget Pages

The applicant should prepare separate detailed budgets including justification for each the CEGS activities, and the MAP activities. In addition, the applicant should prepare a composite budget that is the sum of the CEGS and the MAP activities. In the grant application these must appear in the following order:

Research Plan Page Limitations

The page limit for CEGS P50 grant applications will be expanded to 50 pages for Research Plan items 2-5. Human Subjects and Vertebrate Animals, sections 8-12, have no specific page limits; be succinct. In addition to the Research Plan, the following sections are to be included in the application, observing the stated page limits: The Management and Organization Plan, Data and Materials Dissemination Plan, and Training Plan (not including the Minority Action Plan), combined, may not exceed 12 pages. Text for the Minority Action Plan should be incorporated into the application immediately after the section describing the general training plan. The instructions for preparing the Minority Action Plan, including page limits, are available at http://www.genome.gov/10003996. An ELSI research plan, if included, may not exceed 5 pages.

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 (excluding consortium F&A costs) must carry out the following steps:

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

2) Obtain agreement from the IC staff that the IC will accept the 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 new, renewal, revision, or resubmission applications. See NOT-OD-02-004, October 16, 2001.

Appendix Materials

All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application. Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

The sharing of materials, data, methods, and software in a timely manner has been an essential element in the rapid progress that has been made in genome research. Early in the project, the advisors to the NIH and the Department of Energy (DOE) genome programs encouraged more rapid sharing than had been practiced in most biological research (http://www.genome.gov/10000925). This has become the standard for genome research. In fact, attention to the importance of rapid and wide dissemination of research tools has expanded beyond the genome community. The NIH, as a whole, is interested in ensuring that the information about new methods, technologies, computer software, and as many data developed through federally-sponsored research as possible become readily available to the research community as the basis for further research and development. With the expectation that this will stimulate additional research and thus lead more rapidly to information and products that improve the health of the public, the NIH has issued Principles and Guidance that address the issue of data release (http://grants.nih.gov/grants/policy/data_sharing). All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

This guidance is an integral part of the philosophy of rapid data release in the CEGS program for any large-scale data collection. To the extent that established public databases (e.g., GenBank and dbSNP) have the capability for collecting and disseminating the data that would be collected under a CEGS grant, a plan for the rapid deposition of data into such public databases should be presented in the application. If the established public databases cannot be used for this purpose, applicants should develop and propose specific plans for sharing the data generated through the grant. Similarly, applicants should propose specific plans to share materials, methods, technologies, and software generated through the grant.

The technology transfer practices and policies of the applicant institution, as they relate to resources anticipated to be developed through NIH support of the proposed project, should be described in the CEGS application. If the collaborations supported under the grant will involve commercial entities, the effect this will have on widespread and rapid dissemination of data and materials produced under federal support should also be described. It is to the advantage of applicants and their collaborators to have reached agreement as early as possible on issues related to technology transfer and data and materials dissemination, and to describe these plans in the application. Failure to agree on these issues before submitting the grant may delay the release of funds for consortium arrangements and interfere with research progress. Peer reviewers, NHGRI and NIMH staff, and advisors will evaluate the adequacy of dissemination plans prior to award (see below). Please note that institutional sign-off on the grant application signifies that all relevant components of the institution, including the technology transfer office, have reviewed and approved the document.

Specific Instructions for Foreign Applications

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

Section V. Application Review Information

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

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

2. Review and Selection Process

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NHGRI and in accordance with NIH peer review procedures ( http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

Applications will compete for available funds with all other recommended applications received through this and other NHGRI and NIMH programs. The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. 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 will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weighted 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 scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? If the study is successful, would it simply be an incremental advance, or would it provide a substantial step forward that would likely not be achieved through mechanisms other than this CEGS program? Are these studies relevant to important biomedical problems that can be studied effectively by using genomic approaches? Will technology, research tools, software, scientific approaches, methods of analysis, etc. that are proposed to be developed be of high utility to other scientists? Would these studies have a large effect on the field of genomics and likely be useful to the larger biomedical research community?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is there strong synergy among combined efforts of various investigators and organizational components, or could one or more components or investigators be removed without impairing the accomplishment of central goals? Are the plans adequate for monitoring and ensuring high data quality and cost reduction? Are timelines and milestones appropriate?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Is the level of innovation higher than is typical for investigator-initiated NIH grants? Does the level of technical or conceptual risk inherent in achieving the innovations justify funding under the CEGS program, or would the project likely receive funding through standard mechanisms? Is the risk adequately mitigated by the quality of the scientific and management approach?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Does the P.I. have the ability to lead and coordinate the activities, and develop and implement the management plan, as required for the project's success? Is the level of effort of key personnel adequate? Is there evidence that key personal can collaborate successfully? Does the team of multi- and inter-disciplinary investigators offer novel capability to accomplish the research program?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support, such as any needed expansion of facilities, improvement of infrastructure, or release from other academic duties where necessary? Is there evidence for a strong training and educational environment?

In addition to the above review criteria, the following criteria will be addressed and considered in the determination of scientific merit and the rating:

Management Plan: Is the management plan of high quality? Does it include an effective management structure? Is there a workable plan for decision making to deploy fiscal resources, equipment and human resources to attain the research aims and overall CEGS goals? Are staff well organized and their activities coordinated? Is there an adequate plan for making critical decisions or choices about overall research direction during the project, including substantive mid-course corrections as the results within participating laboratories and progress in the field dictate? Is there an adequate plan to conduct the research in a cost-effective manner?

Training: Is the training plan of high quality and is it likely to be effective in producing well-trained researchers who can develop new genomics approaches and apply them to biological problems? Are effective plans presented to develop new training opportunities and to integrate them with other on-going or planned training? Plans to achieve effective training of underrepresented minorities under the Minority Action Plan will receive separate review as described at http://www.genome.gov/10003996.

ELSI: If an ELSI project is included, the standard review criteria significance, approach, innovation, investigators and environment will be applied. In addition, does the ELSI plan adequately leverage the scientific resources of the project, and is it effectively integrated into the research activities of the CEGS?

NIH considers the following in evaluating Center grant applications:

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 rating:

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

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).

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 on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

Applications from Foreign Organizations: In cases where applications from U.S. institutions include components from foreign organizations, whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

NHGRI and NIMH advisors and staff will consider the adequacy of the dissemination plan as one of the criteria for award. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the negotiated data and resource sharing plans will become a condition of the award. Evaluation of annual non-competing progress reports, the year-03 administrative review, and competing renewal applications will include assessment of grantee s responsiveness to the plan.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

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

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

2. Administrative and National Policy Requirements

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

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement. Given the size and complexity of CEGS projects, reporting of scientific progress is anticipated to require substantially more than the standard two page report. A separate progress report for the Minority Action Plan is to be submitted along with the non-competing progress report. In addition to annual written progress reports, grantees will be expected to participate in, and report results at, CEGS grantee meetings held about once a year. An additional progress report may be requested at the time of the third-year administrative site visit.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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:

Jeffery A. Schloss, Ph.D.
Division of Extramural Research
National Human Genome Research Institute, NIH
Phone: (301) 496-7531
FAX: (301) 480-2770
Email: [email protected]

Direct inquiries regarding scientific issues on the application of genomic approaches to the nervous system and mental disorders to:

Thomas Lehner, Ph.D., M.P.H
Genomics Research Branch
National Institute of Mental Health, NIH
Phone: (301) 443-9869
E-mail: [email protected]

Direct inquiries regarding the Minority Action Plan to:

Bettie Graham, Ph.D.
Action Plan Coordinator
Division of Extramural Research
National Human Genome Research Institute, NIH
Phone: (301) 496-7531
FAX: (301) 480-2770
Email: [email protected]

2. Peer Review Contacts:

Rudy Pozzatti, Ph.D.
Scientific Review Branch
National Human Genome Research Institute, NIH
Phone: (301) 402-0838
FAX: (301) 435-1580
Email: [email protected]

3. Financial or Grants Management Contacts:

Cheryl Chick
Grants Administration Branch
National Human Genome Research Institute, NIH
Phone: (301) 435-7858
FAX: (301) 402-1951
Email: [email protected]

Direct inquiries regarding fiscal matters for projects on the application of genomic approaches to the nervous system and mental disorders to:

Rebecca Claycamp
Grants Management Branch
National Institute of Mental Health, NIH
Phone: (301) 443-2811
FAX : (301) 443-6885
E-mail: [email protected]

Section VIII. Other Information

Required Federal Citations

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

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

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

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

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

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

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

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

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

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

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html), investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA 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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NIH Funding Opportunities and Notices


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