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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 Genomic Science (CEGS) (P50)

Announcement Type
This is a reissue of PAR-08-094.

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-10-202

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

Key Dates
Release Date: May 20, 2010
Letters of Intent Receipt Date(s): June 21, 2010, April 25, 2011; April 25, 2012
Application Receipt Dates(s): July 21, 2010, May 25, 2011; May 25, 2012
Peer Review Date(s): October-November 2010, 2011,2012
Council Review Date(s): January 2011, 2012, 2013
Earliest Anticipated Start Date: April 2011, 2012, 2013
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: May 26, 2012

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
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 in the United States 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. Applicants to the CEGS program are required to submit a parallel application to the Initiative to Maximize Research Education in Genomics (R25) http://grants.nih.gov/grants/guide/pa-files/PAR-09-245.html.

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, methods, 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. For example, the Institutes continue to support research to generate comprehensive data sets, and 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 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.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 otherwise are not possible. 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 e.g., a concept, method, technology or way to analyze data -- that can be identified as having been the outcome of CEGS funding. NHGRI and NIMH 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, we are interested in the product or its precursors (e.g., publications, methods, data) becoming available to the community throughout the duration of the grant; thus active and early sharing of data and resources is a central tenet of the program. 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 not appropriate for this solicitation.

This FOA 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. 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 in a comprehensive manner and 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 FOA 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 FOA.

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.

Leveraging of genomic resources: Preference will be given to the development of genomic methods for eukaryotes where genome sequence and related data are already 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., ENCODE (ENCyclopedia Of DNA Elements) [http://www.genome.gov/10005107], SNPs/HapMap [http://www.genome.gov/10001688], the Mammalian Gene Collection [http://mgc.nci.nih.gov], a Catalog of Published Genome-Wide Associatioin Studies [http://www.genome.gov/26525384], and NHLBI genomics program [http://public.nhlbi.nih.gov/GeneticsGenomics/home/pga.aspx]) will be considered advantageous.

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 described. 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.

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 may be included. 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 research program is available at http://www.genome.gov/10001618. A CEGS application that includes ELSI research should include ELSI scholars in the training program. 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.

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 scientists from diverse backgrounds that are currently 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 diverse scientists from underrepresentedbackgrounds , 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 FOA. 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 U.S. 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/research-funding/training/index.shtml), for expanding the cadre of investigators working in the field of genomics.

2. Diversity Action Plan (DAP)

There is abundant evidence that the biomedical and educational enterprise will directly benefit from broader inclusion. Recent studies have supported the argument that diversity enhances the quality of education in multiple settings. Studies have suggested that racially and culturally concordant scientific staff may be more successful in recruiting individuals from minority groups into clinical trials. Racially similar physician-patient dyads also may be related to greater patient satisfaction in ways that could enhance communication and participation in clinical research settings. There is no question that the need for a diverse workforce permeates all aspects of the nation's health-related research effort.

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 medically underserved 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.

The NHGRI and NIMH want to ensure that the next generation of genome scientists will have representation from populations that are currently underrepresented in genomic science as researchers in genomic science, including African Americans, Hispanic Americans, Native Americans, Alaskan Natives, Hawaiian Natives, natives of the US Pacific Islands, individuals with disabilities, and individuals from disadvantaged backgrounds. The CEGS program is among the initiatives that have been identified as preferred incubators for research education and training in genomics (http://www.genome.gov/10001707). Initiatives targeted to those at the undergraduate level and/or beyond, including the faculty level, are encouraged and will be given the highest priority. The main focus should be on ensuring that individuals: (a) successfully transition to the next career level; (b) remain in a science, technology, engineering, and mathematics (STEM) field; (c) pursue doctoral degrees or advanced training in fields relevant to genomics; and (d) pursue careers in genomics. Examples of how these objectives can be accomplished include, but are not limited to, academic enhancement programs, appropriate laboratory experience; mentoring adequate for the career level; career development activities; enhancements in writing scientific papers and fellowship/grant applications; and developing scientific presentation and interviewing skills. The duration of the research education and training program must coincide with that of the parent grant application.

The types of research experiences that can be supported under this award include, but are not limited to: (1) short-term research experiences for undergraduate and graduate students; (2) up to two years of post baccalaureate research and academic support with the objective of transitioning to a F31 support for graduate school; (3) up to 24 months of graduate school support with the objective of transitioning to a F31; (4) up to 24 months of postdoctoral fellowship support with the objective of transitioning to a F32; and (5) research experiences for faculty to provide preliminary data for research grant applications. Exceptions to accommodate research experiences for high school students will only be made for competing continuations of the parent grant that have in the past supported such students. In such cases, support of high school students must represent less than 10 percent of total support requested.

The proposed research education and training initiative may complement other ongoing research training and education programs at the applicant institution, but the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support and provide added value. The R25 is not a substitute for an institutional research training program (T32) and can not be used to circumvent or supplement Ruth L. Kirschstein National Research Service Award (NRSA) mechanisms.

The NIH encourages all proposed programs to foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals from disadvantaged backgrounds, individuals with disabilities.

CEGS awards will not be made in the absence of a DAP program. If your institution already has a Diversity Action Plan that is funded through NHGRI, contact program staff listed in this FOA.

CEGS Renewals and State of the Art

Renewal grant applications are accepted in this program (up to a maximum of 10 years of funding). 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 Diversity Action Plan programs specifically; they will be held to a high standard for those essential CEGS components.

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

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 the first competing cycle. Subsequent funding for that cycle 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.

The CEGS program, and projects that have been funded under this program, are extremely ambitious. Nevertheless, even for applications that receive outstanding impact/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. Similarly, a project may not receive funding 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.

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:

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.

The CEGS program does not use multiple PDs/PIs.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Number of Applications. Applicants organizations may submit more than one application, provided that each application is scientifically distinct and involves different investigators and scientific topics. An investigator may submit only one application per receipt date.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals. Renewal applications will be accepted.

Section IV. Application and Submission Information

1. Address to Request Application Information

The current 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

Prepare all applications using the PHS 398 application forms in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

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

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.

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): June 21, 2010, April 25, 2011, April 25, 2012
Application Receipt Date(s): July 21, 2010, May 25, 2011, May 25, 2012
Peer Review Date(s): October-November 2010, October-November 2011, October-November 2012
Council Review Date(s): January 2011, January 2012, January 2013
Earliest Anticipated Start Date(s): April 2011, April 2012, April 2013

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:

Ken Nakamura, 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.

Upon 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 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 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

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, and Resource Sharing 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.

CEGS leadership may wish to appoint a team of outside advisors to provide perspectives on progress that the CEGS is making in context of a rapidly advancing field. NHGRI urges CEGS applicants to describe the function and operation of the proposed advisory board, but not to name individuals who will serve on the advisory board, and not to contact any potential candidates before the application is reviewed.

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.

Diversity Action Plan Application

CEGS applicants are required to submit a simultaneous, parallel application to the Initiative to Maximize Research Education in Genomics (R25) http://grants.nih.gov/grants/guide/pa-files/PAR-09-245.html. If your institution already has a Diversity Action Plan that is funded through NHGRI, contact program staff listed in this FOA.

PHS398 Research Plan Sections

All application instructions outlined in the PHS 398 Application Instructions are to be followed, with the following additional requirements:

Budget

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

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations. 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 federallysponsored 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.

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

Review 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:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change 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?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is the level of effort of key personnel adequate? Is there evidence that key personnel can collaborate successfully? Does the team of multi- and interdisciplinary investigators offer novel capability to accomplish the research program?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Is the level of innovation higher than is typical for investigator-initiated NIH grants? Is the risk adequately mitigated by the quality of the scientific and management approach? Does the level of innovation, scientific complexity and integration required for success exceed that which would routinely be supported under other grant mechanisms?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? 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? If ELSI research is included, does the ELSI plan adequately leverage the scientific resources of the project, and is it effectively integrated into the research activities of the CEGS?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or 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?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

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?

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

NIH considers the following in evaluating Center grant applications:

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 Notice of Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the business official.

2. Administrative and National Policy Requirements

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.

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

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. 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]

2. Peer Review Contacts:

Ken Nakamura, 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) 451-5434
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.

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-09-116.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.

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. 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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