Department of Health and Human Services
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov)
Title: High-Throughput-Enabled Structural Biology Research (U01)
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 ().
Program Announcement (PA) Number: PAR-10-214
Catalog of Federal Domestic Assistance Number(s)
Release Date: June 10, 2010
Letters of Intent Receipt Date(s): Letters of Intent should be submitted 30 days before the anticipated receipt date.
Application Submission Dates(s): Standard dates apply; please see
AIDS Application Submission Dates(s): Optional Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date: Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: (Now Expired March 24, 2011 per issuance of PAR-11-176), Previously Changed to May 8, 2011 (Per NOT-OD-11-048) ; Original Date September 8, 2013
Dates for E.O. 12372
Additional Overview Content
Table of Contents
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
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
V. Application Review Information
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
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Dispute Resolution Process
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
This FOA encourages applications to establish partnerships between researchers interested in a biological problem of significant scope and researchers providing high-throughput structure determination capabilities through the NIGMS PSI:Biology network. Applicants should propose work to solve a substantial biological problem for which the determination of many protein structures is necessary. The proteins should be amenable to high-throughput structure determination or should provide suitable targets to motivate new technology development. The proteins generally should be of unknown structure and preferably likely to be of novel structure. Ideally, the solution of these protein structures will also contribute to the understanding of protein sequence-structure relationships in general. The project should involve both studies of protein function by the applicant researchers and structural studies by the PSI:Biology network. Projects may focus on proteins that are the subject of other grant proposals, but the specific aims must clearly differ, both with respect to functional studies to be conducted and with respect to the goal of structure determination.
It is expected that these awards will lead to new collaborations between researchers emphasizing biological function and researchers emphasizing biological structure. It is expected that the results from these collaborations will contribute to understanding many basic and biomedically important research problems as well as to our fundamental understanding of protein structure. Example areas of interest are discussed below.
This FOA is part of a new NIGMS initiative, PSI:Biology [http://www.nigms.nih.gov/Initiatives/PSI/Biology/], that is being established through a series of RFAs (Request for Applications) and PARs (program announcements with ongoing receipt dates and special review considerations, but with no set-aside funds) over the course of the next several years. PSI:Biology represents a significant shift in focus for the Protein Structure Initiative (PSI). The PSI was initiated in FY2000, after extensive dialog with the scientific community, with the ultimate goal of significantly advancing the understanding of the relationship between the sequence of a protein and its three-dimensional structure. The first phase (PSI-1), FY2000-2004, tested whether the concept of high-throughput structure determination was viable and resulted in the development of new methods and technologies, and high-throughput pipelines for all steps along the pathway from targeted sequence to deposition of the solved structure in the Protein Databank (PDB). The second phase (PSI-2), FY2005-2009, applied high-throughput methods, such as those developed in PSI-1, to solve large numbers of proteins of novel structure, revealing new folds and illuminating families of proteins which had no previous representation in the PDB. The goal of PSI-2 was to cover sequence/structure space at a sufficient density that the structure of most proteins could be modeled reliably from their sequences and the known structures of their nearest neighbors in the database. See: http://www.nigms.nih.gov/Initiatives/PSI/ and http://grants.nih.gov/grants/guide/rfa-files/RFA-GM-05-001.html for extensive discussion of the initial goals of the PSI and of structural genomics in general.
In 2008, the PSI Advisory Committee made a number of recommendations about how the PSI might be restructured and refocused, including realigning the mission of any large-scale centers to focus on biologically important questions that would be pursued in partnership with the broader community of scientists. They felt that a number of components of the current PSI could be satisfactorily competed and supported through program announcements (PAs), rather than RFAs; specifically, technology developments for specific stages in the determination of protein structures and methods for improving homology modeling could be supported using PAs. Based on these recommendations, NIGMS staff presented a Concept Clearance document to the NIGMS Council at its January 2009 meeting, and the Council approved those plans, which are being implemented (see RFA-GM-10-005, RFA-GM-10-006 and RFA-GM-10-007). This PAR represents an on-going opportunity to apply for the program that was described more extensively in RFA-GM-10-007 Consortia for High-Throughput-Enabled Structural Biology Partnerships.
Objectives of this FOA
This FOA encourages applications for High-Throughput-Enabled Structural Biology Research projects. These projects will provide the biological problems that will drive the PSI:Biology initiative. The high-throughput centers to be funded primarily through RFA-GM-10-005 will focus up to 70% of their effort on solving structures of targets that are to be determined through the Consortia for High-Throughput-Enabled Structural Biology Partnerships (RFA-GM-10-007), the High-Throughput-Enabled Structural Biology Research projects (PAR-10-214, i.e., this FOA), and through other modes of community nomination of targets. The centers for membrane protein structure determination funded primarily through RFA-GM-10-006 will focus up to 30% of their effort on similarly identified collaborative and community nominated targets. Applicants for this FOA define the general area of science to be studied and the specific proteins for which structures are to be determined. The results should be of interest to a significant number and/or a broad range of scientists. The proteins should be of unknown structure, rather than minor variations on proteins of known structure, e.g., mutations or different bound ligands. Exceptions may be made in compelling cases. Sequence novelty and predicted structural uniqueness of the target proteins is secondary to the importance of understanding their biological function, but is a significant other consideration and is to be assessed as described below under Application Procedures. Protein targets should ideally contribute to coverage of protein sequence, family, and fold space and should provide as much leverage of additional sequence space as possible. Assistance in evaluating this aspect of proposed protein targets is available through the Submit Targets [http://kb.psi-structuralgenomics.org/KB/SubmitTargets] module of the PSI-Structural Genomics Knowledgebase as described under Application and Submission Information, Section IV. 6. Other Submission Requirements and Information, "Section C. Preliminary Results." Sources may be either prokaryotic or eukaryotic. In some cases, only the structure of the exact protein from a specific organism will suffice; however, the odds of success will improve if related proteins of the same family or of other organisms can also provide the needed structural information to generate an adequate model for the target. Protein targets should be amenable to high-throughput approaches or should drive technology development by the PSI:Biology network centers. Intermediate products of the structure determination pipeline (clones, proteins, procedures) between gene sequence and structure solution should be of value, even if the structure is not solved. These intermediate products must be deposited in the PSI-Materials Repository and the PSI-Structural Genomics Knowledgebase, or otherwise shared with the broad scientific community.
In addition to specifying targets to be solved, the biological partnerships will provide the linkage between structure and function by proposing and conducting studies that will contribute to understanding the biological function of the proteins and their structure-function relationships. This work may involve utilization of results and resources generated by the PSI:Biology network beyond the solved structures, e.g., the proposed work may utilize vectors, clones, reagents, models and other resources generated by the network. Targets proposed by the partners may drive technology development for structure determination, informatics, and model generation that will be carried out jointly with the PSI:Biology network. Partnerships might also develop ideas about protein structure based on the database of solved PSI structures (and others); e.g., evolution of protein families and fundamental protein structure motifs. The partnerships will ensure the biological impact of the solved structures by facilitating the interpretation of structural results, putting the structural studies in their biological context, and actively contributing to dissemination of PSI:Biology results. As partners, both applicants and the PSI:Biology network should have a stake in the outcome of the research. The PSI:Biology network is not intended to provide simply a structure determination service. The partnerships will establish consortium arrangements with one or more of the PSI:Biology network centers to be established during the initial year of the award.
Projects that are amenable to high-throughput structure determination will likely have the following general requirements:
The following specific areas of scientific opportunity were identified during the Future Structural Genomics Initiatives meeting. Please see the meeting report for additional description:
The above list should not be considered to be comprehensive. Applications proposing research outside the above areas but still appropriate to the goals of PSI:Biology are welcome.
PSI:Biology Network Operations and Governance
All awarded components of the PSI:Biology initiative will become part of a network of researchers that will be governed by the "Cooperative Agreement Terms and Conditions of Award" that are discussed in Section VI.2.A "Award Administration Information". A single overall PSI:Biology Network Steering Committee (Steering Committee) will be responsible for overall governance. A PSI Investigators Intranet website to be maintained by the Knowledgebase will facilitate communications among PSI:Biology network investigators.
After initiation of the PSI:Biology network, the Steering Committee and the PSI Advisory Committee (see immediately below) will meet jointly with NIH staff to determine how to best carry out the overall distribution of targets throughout the network, including those proposed by the funded Consortia for High-Throughput-Enabled Structural Biology Partnerships. Further refinement of target distribution plans will be carried out by these same groups on a regular basis throughout the lifetime of the initiative. Partnership representatives will participate in all discussions of target distribution and network capacity allocation, along with representatives of the high-throughput and membrane protein structure determination centers.
Each center will be expected to abide by the decisions of the Steering Committee and to provide due diligence in the pursuit of their assigned targets. Functional study design and execution funded by the U01 awards will be the responsibility of the awardees with minimal input from the Steering Committee, but it is expected that a collegial collaborative relationship will be developed with structure determination center investigators working specifically on the awardee’s targets.
External Input to the Network
The PSI Advisory Committee will provide external input to the PSI:Biology Network Steering Committee and to NIH staff. Individual components of the network may have their own External Advisory Committees, if the scope of the component warrants such a committee.
Commitment to Diversity
Reports from the National Science Foundation (e.g., Broadening Participation at the National Science Foundation: A Framework for Action, August, 2008) and the National Academy of Sciences (e.g., Advancing the Nation’s Health Needs: NIH Research Training Programs, National Research Council, Washington, DC. National Academy Press, 2005) emphasize the need for a well-trained diverse scientific workforce. The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities. The NIGMS is committed to promoting and advancing the diversity of its biomedical scientific workforce. See: http://www.nigms.nih.gov/News/Reports/workforcediversity_100307.htm.
Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.
The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:
A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the report Women, Minorities, and Persons with Disabilities in Science and Engineering, 2007, p. 262). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans or Blacks, Hispanic Americans or Latinos, American Indians or Alaska Natives, Native Hawaiians or other Pacific Islanders. In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be included in the Recruitment and Retention Plan to Enhance Researcher Diversity (see below, Section IV.6).
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.
C. Individuals from disadvantaged backgrounds who are defined as:
1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates (a) have qualified for Federal disadvantaged assistance; or (b) have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program; or have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.
2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.
Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.
In order to promote an NIGMS-supported biomedical workforce that is diverse, applicants responding to this initiative must propose creative ways to enhance and/or successful ways to ensure diversity on their research teams.
The PSI:Biology research groups should reflect the commitment of the NIH and NIGMS to enhance the diversity of the scientific workforce and applications should include recruitment and retention plans to enhance researcher diversity..
Sharing of Data and Material Resources under this Initiative
A central feature of the PSI:Biology initiative is the timely deposition and sharing of data through the PSI-Structural Genomics Knowledgebase, and timely sharing of research resources through depositions to the PSI-Materials Repository and by other mechanisms. Details of these requirements are described under the "Cooperative Agreement Terms and Conditions of Award" that are discussed in Section VI.2.A "Award Administration Information".
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism of Support
This funding opportunity announcement (FOA) will use the U01 cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award". The U01 mechanism should be used regardless of the number of investigators. Subprojects should not be designated. The project should be presented in a single integrated research plan as described under Section IV.6. Other Submission Requirements and Information. However, the various specific aims may be the primary responsibility of different investigators.
Projects funded as cooperative agreements through this FOA may be continued beyond the initial award period through application for a grant award in response to any appropriate FOA. Plans to reissue this FOA in the future are indefinite.
This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see ).
2. Funds Available
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.
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.
The following organizations/institutions are eligible to apply:
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. However, such institutions may be included as part of consortium applications submitted by any other type of eligible institution.
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.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
Because the proposed projects are intended to be managed as an overall unified program of research, subprojects should not be designated. Subcontracts may be used, but the work to be done by contractors should be well integrated into the overall project. In the case of multiple PD/PI applications, awards will not be allocated to individual PDs/PIs by the NIH and the Notice of Award will include only a single overall budget. Budget allocation should be determined flexibly by the investigators in consultation with NIH staff as the research proceeds.
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 may submit more than one application, provided that each application is scientifically distinct.
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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and 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. Applicants may submit renewal applications.
1. Address to Request Application
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.
further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be prepared using the 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 in item (box) 2 only of the face page of the application form and the YES box must be checked.
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled “Multiple PD/PI Leadership Plan”, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Additional information is available in the PHS 398 grant application instructions.
3. Submission Dates and Times
See Section IV.3.A. for details.
Submission, Review and Anticipated Start Dates
Letter of Intent Receipt Date(s): Letters of intent should be submitted at least 30 days prior to the anticipated receipt date.
Application Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
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.
Ward Smith, Ph.D.
Director, Protein Structure Initiative
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
45 Center Drive, 2AS.13C
Bethesda, MD 20892-6200
Telephone: (301) 594-0828
FAX: (301) 480-2004
3.B. Sending an Application to the NIH
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 plus
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:
Helen R. Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Building 45, Room Number 3AN.12F
Bethesda, MD 20892
Telephone: (301) 594-2881
3.C. Application Processing
Applications must be submitted on or before the application
receipt/submission dates described above (Section
IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
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.)
Expenditure of funds
under this award will be subject to the Cooperative Agreement Terms and
Conditions of Award described below. These terms will control the flow of
funds from the awardee institution to the PSI:Biology network investigators.
Funds awarded for support of work to be done through consortium arrangements
involving the PSI:Biology structure determination centers may not be rebudgeted
without NIH permission.
6. Other Submission Requirements
For cooperative agreements, awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information."
PHS 398 Research Plan Sections
All application instructions outlined in the PHS 398 Application Instructions are to be followed, with the following additional requirements:
Up to one additional page each may be used for the Management Plan, the Plan for Increasing Researcher Diversity, the Plan for Data Sharing and Dissemination, the Plan for Sharing Material Resources, and the Intellectual Property Plan. These should be attached immediately following the Research Strategy section.
Specific Aims. Applicants should succinctly state the scientific objectives of the PSI:Biology research project and should clearly delineate what work is to be done by the applicants and what is to be done by the PSI:Biology network centers.
Research Strategy. Applications should follow the general outline for R01 grant applications using the Restructured Application Instructions (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-149.html) to discuss in order: a) Significance; b) Innovation; c) Approach (including Preliminary Studies or Progress Report for Renewal and Revision Applications.)
Under significance, the applicants should provide a strong biological and/or biomedical motivation for the proposed studies. This should include information about the significance of the overall problem and of the particular contribution that determining the proposed structures will make to understanding or progress in the field. This section should also explain how the work to be done by the investigators will integrate with the work to be carried out by the PSI:Biology network centers to be funded through RFA-GM-10-005 Centers for High-Throughput Structure Determination and/or RFA-GM-10-006 Centers for Membrane Protein Structure Determination. For example, who will be responsible for protein production, which experiments will be performed at which sites, how experiments on function will be informed by structural results.
Under Approach, applicants should describe in detail how the work is to be conducted. This should include detailed plans for work to be conducted in the applicants' laboratories. Work to be conducted by the PSI:Biology network centers may be described in more schematic form but should demonstrate an understanding of the general capabilities and challenges of high-throughput structural biology.
Applicants should include as preliminary studies any analysis that they have carried out with respect to the sequence and structure space coverage/leverage of their proposed targets. For example, this material should include information about the solved structures of the nearest known family or superfamily members (percent homology of proposed targets to nearest neighbors). It should include information about the likely leverage that a solved structure would provide for the modeling of other proteins of unknown structure. This type of information is available through the PSI-Structural Genomics Knowledgebase and it is highly recommended that applicants subject their proposed target sequences to the analysis available there through the Submit Targets module (http://kb.psi-structuralgenomics.org/KB/SubmitTargets). The results should be presented in an appendix to the application. Similarly, applicants should search the PSI-Materials Repository to determine which plasmids relevant to their project have already been deposited and include plans to make use of such materials. This material should also be included in the appendix.
Other preliminary results, including preliminary studies on biological function, may be included as the investigators wish. In the case of investigators who have on-going collaborations with currently funded PSI-2 research centers, it will not likely be possible, nor necessary to obscure these connections. However, since it is not known whether these same investigators will be funded as part of the PSI:Biology initiative and all funded components of the PSI:Biology initiative will be expected to work together as a team, applicants should not propose specifically to continue working with their current collaborators. Rather they should propose to work with the network and highlight preliminary results and methods that may be translated to one or more of the funded centers when the new network is established.
Management Plan: Applications must include a project management plan, which may include the Multiple PD/PI Leadership Plan as a subheading (if the application is designated a Multiple PD/PI application). Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" that are discussed in Section VI.2.A "Award Administration Information" and applicants should explain how they plan to meet these terms and conditions. Applicants must indicate their willingness to participate in the PSI:Biology Network Steering Committee and how they anticipate managing the interactions between the applicants' laboratories and those of the PSI:Biology network. Depending on the scope of the project, it may be appropriate to plan for an External Advisory Committee. Although the plan should be set forth, names of potential members should not be included. Potential members should NOT be contacted, named, or appointed until after an award is made. If the investigators are now or have been involved in previous projects with advisory structures, however, the names of present and recent past advisors should be identified in the Participant Affiliations page described above. Similarly depending on scope, it may be appropriate to plan an annual meeting to bring all participating investigators together at least annually. Means for more frequent communication should also be described.
Recruitment and Retention Plan to Enhance Researcher Diversity: Applicants must propose ways to reflect the NIH and NIGMS commitment to enhancing the diversity of the scientific workforce. Applicants should provide information on the diversity of the proposed research teams and plans to enhance and/or ensure the continued diversity of their research teams. This section of the application will not be considered by the peer review group, but will be considered by NIH staff as part of the award process.
Plan for Data Sharing and Dissemination: Applicants should describe how they will contribute to data sharing and dissemination in addition to the activities described under the Cooperative Agreement Terms and Conditions.
Plan for Sharing Material Resources: Describe plans for research resource sharing in addition to the activities described under the Cooperative Agreement Terms and Conditions of Award.
Intellectual Property Plan: An institution's stance must be consistent with the goals of advancing and not hindering future research.
This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A single overall project budget should be presented on form page 4 and a budget for the entire proposed period of support on form page 5. Subproject budgets are not allowed. Consortium budgets should be included as necessary. Consortium subcontract indirect costs (Facilities and Administration, including F&A costs required to set up and maintain subcontracts) do not count against the upper direct cost budgetary limits for this announcement; however, they will count against the overall total cost limit of $2.5 million.
The budget should include personnel, consultant costs, equipment, supplies, and other expenses costs that will support work to be performed in the applicants' laboratories. The budget should include under Other Expenses funds that are expected to support the determination of structures by the PSI:Biology network centers. No more than one-half of the total direct costs budget should be designated for this purpose. The estimated cost per structure depends on the nature of the protein target and the probability that it will be amenable to high-throughput structure determination. The current cost for solution of soluble protein targets by PSI-2 is close to $50,000. However, since a large part of the costs for structure determination will be awarded to the centers through RFA-GM-10-005, use an estimate of $10,000 per structure when preparing the budget. For more difficult protein targets (e.g., membrane proteins and complexes) higher figures should be used and the estimates justified. These structure determination funds will not be awarded by the NIH until the grantee, in consultation with the PSI:Biology Steering Committee, has identified the specific PSI:Biology high-throughput centers and/or membrane protein centers with which the grantee investigators will be working. Once these consortium arrangements are in place, NIH will provide funds to the parent award to support the required subawards. For planning purposes, estimate subaward F&A costs at 50%. Actual subaward F&A costs will be recalculated once the consortium institutions have been identified.
Applicants should plan for and may request funds to support the travel of the principal investigators and one or more other scientific staff members to attend at least two PSI:Biology initiative meetings of up to two days each per year. This is in addition to requesting travel funds for normal attendance at scientific meetings.
Applicants should request funds to support an annual meeting of all partnership investigators and also funds to support travel expenses and consultant costs of an Annual External Advisory Committee meeting, if the scope of the project warrants these activities.
Applicants should request funds to support any special activities proposed under the Plan for Data Sharing and Dissemination and the Plan for Sharing Material Resources.
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
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.
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.
For this FOA, the following materials may be included in the appendix in addition to those specified in the general NIH guidelines. 1) Output from searching the PSI-Biology Knowledgebase Submit Targets module for data on the relationship of proposed targets to already proposed targets and known structures. 2) Output from searching the PSI-Materials Repository PSI-Materials Repository for previously deposited plasmids relevant to the proposed research.
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 .
Resource sharing requirements of the PSI:Biology initiative go beyond the NIH policies described above and are included in the Cooperative Agreement Terms and Conditions described below.
Only the review criteria described below will be considered in the review process.
Review and Selection Process
Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIGMS 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.
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?
Does the proposed problem make appropriate use of the capabilities of the PSI:Biology network centers for structure determination? Will the solution of the proposed structures by the PSI:Biology network centers contribute to solving a biologically important problem? Will the solved structures contribute to the secondary goal of determining novel protein structures and increasing the coverage of sequence/structure space? Do the proposed targets pose challenges that will stimulate technology development? Does the work to be conducted in the applicant investigators' laboratories make a significant contribution to solving the biological problem?
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? What is the evidence that the investigators will work well in a collaborative environment? Do the investigators demonstrate the potential to be interactive and effective members of the PSI:Biology network? Do the investigators provide capabilities for functional characterization of proteins that complement the structural capabilities of the centers? For applications involving more than one investigator, is there evidence of synergy among the members of the partnership or the potential for such synergy to develop? Do(es) the PD/PIs have the administrative skills, experience, and/or potential to manage a project of the proposed scope?
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? Does the partnership bring together collaborations between researchers in ways that will lead to new scientific insights?
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
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?
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?
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 an adequate plan presented to assure the productive and collaborative management of the project and interactions with other components of the PSI:Biology network?
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.
Applications from Foreign Organizations. Foreign institutions are not allowed in this FOA.
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.
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:
3. Anticipated Announcement and Award Dates
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.
and Retention Plan to Enhance Researcher Diversity will be considered by NIH
staff as part of the award process and a revised plan may be requested prior to
award. The final accepted version of the plan will be referenced as a
condition of award.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms 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).
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
2.A. Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
2.A.1. Project Director/Principal Investigator (PD/PI) Rights and Responsibilities
The Principal Investigator will have the primary responsibility for:
Awardees will retain custody of and have primary
rights to the data and software developed under these awards, subject to
Government rights of access consistent with current HHS, PHS, and NIH policies.
2.A.2. NIH Responsibilities
NIH project scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
The PSI:Biology Network Director
The PSI:Biology Network Director will be the NIH extramural staff member with leadership responsibilities for the management and coordination of the overall PSI:Biology initiative. The PSI:Biology Network Director will serve as a Scientific Liaison to the overall PSI:Biology Network and all of its components and will be a voting member of the PSI:Biology Network Steering Committee (Steering Committee), but will not direct the scientific activities of any the PSI:Biology awarded component (whose direction is the responsibility of the Project Director/Principal Investigator).
The PSI Network Director will:
The PSI Network Director will not also serve as the NIH program official for any component of the PSI:Biology network.
The Scientific Liaisons will:
Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
The NIH Program Directors will:
The assigned program director for a component
of the PSI:Biology network may not also serve as a Scientific Liaison for
2.A.3. Collaborative Responsibilities
PSI:Biology Network Steering Committee
The PSI:Biology Network Steering Committee (Steering Committee) will be the main governing body of the PSI:Biology network. Membership will include the Project Directors/Principal Investigators of the High-Throughput Structure Determination Centers, the Centers for Membrane Protein Structure Determination, the Consortia for High-Throughput Enabled Structural Biology Partnerships, the PSI-Structural Genomics Knowledgebase, and the Materials Repository, the NIH Scientific Liaisons, and others as nominated by the PSI:Biology Network Director. In the case of awards involving Multiple PD(s)/PI(s), each PSI:Biology component will be entitled to one voting member. The NIGMS/NIH Scientific Liaisons and the PSI:Biology Network Director will serve as voting members of the Steering Committee and attend its meetings. Total NIH representation on the Steering Committee will make up no more than 40% of the voting members. Other members of the NIH staff may also attend the Steering Committee meetings. The leaders of other national and international structural genomics projects may be added to the Steering Committee as non-voting members, as determined appropriate by the PSI:Biology Network Director.
The Steering Committee will:
Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.
PSI Advisory Committee
The PSI Advisory Committee is a working group of the NIGMS Advisory Council. It will advise NIH staff and the Council on the management, progress, and plans for the PSI:Biology initiative. The membership will be appointed by the PSI:Biology Network Director, following consultation with the director of NIGMS. Members will include at least one NIGMS Advisory Council member, plus additional consultants as deemed necessary to provide appropriate guidance to the NIGMS Advisory Council.
The PSI Advisory Committee will:
Goals and Milestones
Appropriate goals and annual milestones for each of the components of the PSI:Biology network will be set to ensure that the overall goals of the initiative are met. Initial milestones will be determined by negotiation between the applicant and the NIH Program Director assigned to the application during the award process and will be included in the Terms and Conditions of Award. Scientific Liaisons may assist the PD(s)/PI(s) in setting milestones, but do not have authority to approve them. This authority rests with the NIH Program Director. Milestones will be further refined as the PSI:Biology initiative evolves with input from the Steering Committee and PSI Advisory Committee and renegotiated annually as part of the non-competing continuation award process. The NIH may reduce or withhold funds for failure to meet milestones agreed upon by the investigators and NIH staff.
The PSI:Biology Network Steering Committee will produce an annual report on the progress made toward the annual goals and milestones. The report will be delivered to the NIGMS staff and PSI Advisory Committee within one month of the annual meeting.
Data Sharing Policies
The PSI:Biology network will be governed by the Data Sharing Policies that have governed PSI-1 and PSI-2. Coordinates of solved structures, along with structure factors, MUST be deposited in the Protein Databank within four weeks of completing the refinement of the structure. Data must be released by the PDB to the public immediately, unless the dataset is designated as a "technology development data set" to be used in CASP-like tests of software development. In any event, ALL structural data must be made public within eight weeks. In addition, protein targets of the PSI:Biology network (including those of the partnerships) must be entered in the TargetDB upon assignment to any PSI:Biology network structure determination component. Furthermore, progress on these targets must be updated on a monthly basis by either the component to which the structure determination has been assigned or by the partnership that has proposed the target for structure determination. As work progresses, appropriate data must be entered in the PepcDB regarding the methods and success or failure of various steps in the structure determination pipeline in a timely fashion. Finally, all components of the PSI must abide by all NIH policies for sharing of published information through PubMedCentral and must also abide by policies of the PSI:Biology network requiring the deposition of information about publications and other activities in the PSI-Structural Genomics Knowledgebase. Participants must also contribute appropriate information to the PSI-Investigators intranet website as necessary to facilitate communication between the various components of the PSI.
PSI:Biology Resource Sharing Policies
All funded components of the PSI:Biology network are expected to deposit vectors and clones developed with PSI:Biology funding or used in PSI:Biology research into the PSI-Materials Repository.
Intellectual Property Policies
Normal NIH guidelines regarding intellectual property will apply to these grants. However, it is expected that the above data sharing and experimental resource sharing activities will take place in a timely fashion, even if IP protection activities are delayed.
Dispute Resolution Process
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to dispute resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
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.
In addition to the Non-Competing Continuation Grant Progress Report (PHS 2590) and reports on the operation of the overall PSI:Biology network to be produced by the PSI:Biology Network Steering Committee and the PSI Advisory Committee, each Contact Principal Investigator will be required to submit annual highlights of progress that will be shared with other members of the PSI:Biology network via the Knowledgebase. These reports will be in the form of text documents (or PDF files) with figures, tables, and formats to be determined by the PD(s)/PI(s). The reports are intended to facilitate coordination of effort and sharing of methodological advances.
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.
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
1. Scientific/Research Contacts:
Ward Smith, Ph.D.
Director, Protein Structure Initiative
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Building 45, Room Number 2AS.13C
Bethesda, MD 20892
Telephone: (301) 594-1158
2. Peer Review Contacts:
Helen R. Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Building 45, Room Number 3AN.12F
Bethesda, MD 20892
Telephone: (301) 594-2881
3. Financial or Grants Management
Earl C. Melvin
Grants Administration Branch
Division of Extramural Research
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Building 45, Room Number 2AN.32E
Bethesda, MD 20892
Telephone: (301) 594-3912
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
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
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this 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
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
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
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.
Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (), 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 .
Standards for Privacy of Individually Identifiable
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.
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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