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 Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/)

Title: Technology Development for High-Throughput Structural Biology Research  (P01)

Announcement Type
New

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-10-074

Catalog of Federal Domestic Assistance Number(s)
93.859

Key Dates
Release Date: January 4, 2010
Letters of Intent Receipt Date(s): Not Applicable.
Application Submission Dates(s): Standard dates apply; please see http://grants.nih.gov/grants/funding/submissionschedule.htm
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: May 8, 2013

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
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The program project mechanism is designed to support research in which the funding of several interdependent projects offers significant scientific advantages over support of these same projects as individual regular research grants. Potential applicants are strongly encouraged to contact the NIGMS program staff listed at the end of this announcement for guidance about the areas appropriate for program project grant applications and for the preparation of the application itself (see http://www.nigms.nih.gov/Research/Application/ProgProjFundPolicies.htm for policies related to NIGMS program project funding).

Successful program projects generally bring together scientists to apply complementary approaches to work on an important well-defined problem.  In addition to individual research projects, applicants may propose one or more Shared Resource Cores if needed for the proposed research.  Each Shared Resource Core must provide support and enhance the productivity, cost-effectiveness, and/or research outcome of at least two of the proposed research projects.  New cores may be proposed and/or existing cores may be augmented to support the proposed research.  In this way the program project can facilitate the support of essential shared core facilities, e.g., major equipment, although the need of a group of investigators for a major piece of equipment or a core facility does not in itself justify a program project grant. Administrative cores, except in special, well-justified circumstances, will not be allowed. Further, it is expected that successful program projects will establish effective collaborations, particularly in emerging areas of research, that extend beyond the life of the program project grant itself.  Hence, a program project generally has a finite lifetime.

Normally, a program project consists of three to five individual, interdependent projects from different investigators.  All of the projects must be relevant to the common unifying central theme, focus, and the overall objective of the entire program project.  Each individual project should reflect a self-standing scientifically meritorious research effort.  In addition, however, the individual projects should be clearly interrelated and synergistic so that the research ideas, efforts, and outcomes of the program as a whole will offer a distinct advantage over pursuing the individual projects separately. The option for multiple PDs/PIs is allowed.  The use of this option allows, for example, the designation of any (or all) of the leaders of the individual projects or cores as a PD/PI of the overall application.  If this option is used, it is expected that one of the PDs/PIs will be identified as the “lead PD/PI” and that person will be responsible for coordinating the entire program project. The scientist designated as the lead PD/PI bears responsibility for the overall scientific leadership and fiscal management of the program project grant.  It is expected that each of the collaborating scientists responsible for the individual projects will be independent investigators.  In addition, the program project and each individual project must represent a significant effort on the part of the participating scientists and be distinct from their other funded efforts.  If individuals have substantial support in areas closely related to the program project, their support should be folded into the program project.  If their support cannot be folded in, they may participate as associate members.  Associate members have full use of, for example, core facilities and contribute to the overall collegiality of the project, but they derive no financial support from it. 

Purpose

This FOA issued by the National Institute of General Medical Sciences (NIGMS), National Institutes of Health, encourages grant applications from institutions/organizations that propose to develop novel technologies and methodologies underpinning high-throughput structural biology. Applications for new ideas and approaches for protein production and structure determination for classes of challenging proteins are appropriate. Projects related to high-throughput structure determination by X-ray crystallography and NMR, as well as projects addressing other constituent tasks of structural biology, including structural genomics, are relevant to this FOA. Applications should focus on methods development to solve challenging proteins that are not currently amenable to high-throughput structural biology.  These challenging proteins include, but are not limited to, membrane proteins, small protein complexes, and proteins from human and other higher eukaryotes. Successful applicants will be a component of PSI:Biology, described below.

Background

This FOA is part of a new NIGMS initiative, PSI:Biology [http://www.nigms.nih.gov/Initiatives/PSI/Biology/], that will be established through a series of five RFAs (Request for Applications) and three PARs (program announcements with on-going 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 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).

Objectives

The purpose of this FOA is to encourage research applications on the development of methodologies and technologies for macromolecular structure determination in a high-throughput mode. Applicants should propose new ideas for protein production, structure determination and the other constituent tasks of structural biology for classes of challenging proteins. Classes of challenging proteins include, but are not limited to, complexes between small proteins, human proteins and other higher eukaryotes, and membrane proteins.

The proposed research should focus on technology and methodology development to overcome major bottlenecks of high-throughput structural biology.  Emphasis will be on classes of challenging proteins that are not currently amenable to high-throughput methods. Applicants must show that their research will have a major impact on the improvement of high-throughput structure determination.  In addition, applicants must present plans for the development of innovative new methods and technologies that have wide applicability to structural biology and are both portable and scalable.  The formation of multidisciplinary research teams from multiple institutions and scientific fields is encouraged.  Rapid release of data into the public databases, consistent with the requirements of PSI:Biology, will be required.

Applicants must describe the major bottleneck(s) to be addressed by their project and the expected impact.  NIH staff has identified three major bottlenecks appropriate for this research.  Applicants are encouraged to submit applications for projects that address one or more of the following three bottlenecks or other major ones.

1. Membrane proteins. The difficulty of producing and determining the structures of members of this large and important class of proteins is well known. Although the expression of membrane proteins is especially difficult, other tasks leading to their structure determination are also hard. Development of innovative methods for membrane protein production (expression, purification, solubilization, etc.), crystallization, and structure determination are needed. The goals of the PSI:Biology require a considerable increase in the number of unique membrane protein structures. 

2. Proteins from human and other higher eukaryotes. Lower production yields for these proteins have limited the number of eukaryotic structures. Problems that need to be solved include inadequate cDNA libraries, unknown ligands and cofactors, post-translation modification and missing or unknown binding partners. 

3. Protein complexes. In many cases, the expression, purification, high solubility, and crystallization of a protein are unsuccessful without the inclusion of the other member or members of an interacting pair or small complex. Co-expression and co-crystallization are often required for successful structure determination. Methods for addressing these issues are needed.   

Applicants may propose projects focused on other major bottlenecks but must justify their choice and explain the expected benefits to PSI:Biology.  

This program is a component of NIGMS PSI:Biology. The goal of the PSI:Biology initiative will be to test whether the new paradigm of high-throughput structure determination via highly organized networks of investigators can be applied to a broad range of biological problems.  It will consist of five main components, established through RFAs with set-aside funds encouraging applications for Cooperative Agreements:  1) Centers for High-Throughput Structure Determination; 2) Centers for Membrane Protein Structure Determination; 3)  Consortia for High-Throughput-Enabled Structural Biology Partnerships; 4) the PSI-Structural Genomics Knowledgebase; and 5) the PSI-Materials Repository; plus three additional components supported through on-going PARs: a)  Technology Development for High-Throughput Structural Biology Research; b) Technology Development for Protein Modeling; and c) High-Throughput-Enabled Structural Biology Research. The core of the PSI:Biology network will consist of investigators from these components  who will be expected to establish meaningful collaborative interactions with  PSI:Biology researchers. The network will be managed collectively through the PSI:Biology Network Steering Committee which will include representatives of the PSI:Biology components and NIH staff.

Participation in the PSI:Biology network is required, including collaboration with other investigators of PSI:Biology. Applicants will be required to deposit their coordinates and other structure data (structure factors or NMR restraints) in the PDB within four weeks of completion and to provide information on structure targets and structure solution to the PSI Knowledgebase TargetDB and PepcDB databases.  Applicants must describe in the Research Strategy portion of the application how they intend to participate in the network of interactions among members of PSI:Biology. Participation in PSI:Biology activities, such as meetings held jointly with other PSI:Biology participants, is expected. Other forms of collaboration with the PSI:Biology centers [http://www.nigms.nih.gov/Initiatives/PSI/Biology/] or other large-scale experimental structure determination projects are strongly encouraged.  The PSI Knowledgebase hosts a portal for access by the broad scientific community to the structures, publications, and technology generated by PSI:Biology. Collaboration with the PSI Knowledgebase in these activities is required. The plans for interactions with PSI:Biology will be evaluated during peer review and must be approved by NIGMS staff prior to award.

Software Sharing

Any proposed software to be developed under this program must be freely available to all biomedical researchers and educators.  There is no prescribed single license for software produced under this program.  The terms of the software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.  The terms of software availability should also include the ability of researchers outside the project to modify the source code and to share modifications with other colleagues as well as with the original developer.  The application should include a written statement from the officials of the institution responsible for intellectual property issues, to the effect that the institution supports and agrees to abide by the software dissemination plans put forth in the application.  If software development is to be included, the applicant must submit a software sharing plan. The plan for software sharing will be evaluated during peer review, and the final version of any accepted software sharing plans will become a condition of the award of the grant. The software sharing plan should be included as part of the Resource Sharing Plan.

Commitment to Diversity

The NIH and the NIGMS are committed to promoting and advancing the diversity of the scientific workforce.  See:  http://www.nigms.nih.gov/News/Reports/workforcediversity_100307.htm. Applicants responding to this FOA must propose creative ways to enhance and/or successful ways to ensure continued diversity on their research teams.  Reports from the National Science Foundation and the National Academy of Sciences emphasize the need for a well-trained diverse scientific workforce. 

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.

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.

The PSI:Biology research groups should reflect the resolve of the NIH and NIGMS to enhance the diversity of the scientific workforce and should include a recruitment and retention plan for increasing workforce diversity.

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 P01 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

The total project period for an application submitted in response to this FOA may not exceed five years. For applications seeking initial funding in FY2010, an upper limit of $6.1 million direct costs (exclusive of subcontractual facilities and administrative costs) for the entire five-year period may be requested. Under certain circumstances, with the concurrence of NIGMS staff, additional funds may be requested and provided for major pieces of equipment.

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.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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 participate as members of consortia or subcontractors on the application.

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.

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 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 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) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Applications must be prepared using the 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.

SPECIAL INSTRUCTIONS

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, a new 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 (NoA).

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates
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

A letter of intent is not required for the funding opportunity.

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 five signed photocopies in one package to:

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

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

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.)

6. Other Submission Requirements

Special Instructions

The program project grant application should be structured as a series of separate but interrelated project proposals. The following format should be used:

Form Page 2 - Description, Performance Sites, and Key Personnel: Under “Description,” state the proposed program’s broad, long-term objectives, specific aims, and the significance to the goals of this FOA. Define the relevance of each proposed project and shared resource core to the overall theme and goals of the program. List all performance sites and all Key Personnel and Other Significant Contributors for the entire P01, beginning with the PI/PD(s) and then listing all other Key Personnel alphabetically. Include all project and core leaders, co-leaders, co-investigators, and consultants and consortium collaborators (if applicable and if these individuals will devote measurable effort to the project).

Form Pages 4 and 5 – Detailed Budget for Initial Budget Period; Budget for Entire Proposed Period of Support: Prepare a detailed composite budget for all requested support categories for the first years using Form Page 4 and a summary budget for the entire proposed period of support using Form Page 5 of the PHS 398 application. Prepare detailed and summary budgets for individual projects and cores as well. In the upper left-hand corner of the initial year and summary budget forms, identify the project or core. If applicable, provide additional budget pages pertaining to Consortium/Contractual arrangements (following the standard PHS 398 instructions).

Biographical Sketches: Compile all biographical sketches after the Overall Budget, starting with the PD(s)/PI(s) followed by all other investigators in alphabetical order. Do not repeat biographical sketches in the individual research projects or shared resources cores.

Program Overview:  Summarize the overall goals and significance, the overall theme and integration, the overall research strategies, preliminary studies and progress (for competing renewal applications), the overall institutional resources and environment, and the overall organization and administrative structure for the P01 as a whole. The overview section must contain justification for the program project grant mechanism and describe those goals that are not readily attainable through individual research project grants.  This section should include:  a description of the objectives of the program as a whole that delineates the relationship of the individual research projects to the entire program project and the special benefits to be achieved by funding as a program project grant rather than as a series of individual research grants; a list of participating personnel; a description of facilities available including major instruments and special program resources; administrative arrangements for overall scientific leadership, quality control, and management of the program project grant; and  a separate overall listing of the proposed person months on the program project grant and actual and pending research support from all sources for each project leader (including person months  effort devoted to each project). This section must also detail the relationship of existing support to the proposed program project and describe planned modifications to that support in the event of funding, for example, folding in support for related funded research. The length of this section should be no more than 12 pages, exclusive of budget, biosketches, list of participating personnel and other support information.

Multiple PI Leadership Plan (if applicable). If the multiple PDs/PIs option is used, the new required section describing the Multiple PI Leadership Plan (see below) should be inserted in the application after the Program Overview. There is no page limit for this section, but applicants should be specific and concise.

Individual Research Projects: Each P01 program project application must include a minimum of three individual (albeit connected) research projects each of which is pertinent to the central theme of the program. Each research project should be prepared according to the standard PHS 398 instructions. The overall format and page limits for an R01 application apply to each of the component projects.  Each individual project of a program project grant should represent both an independent and an interdependent research effort. The cover page, a description of the research to be conducted and any justification for human and animal experimentation, if applicable, should be included. Do not repeat the individual budget pages and biosketches. The special benefits associated with being part of the program project must also be addressed. If support of core resources is requested, a separate component describing and justifying these should be included.  For each individual project, page limits are 1 page for the Introduction in Resubmission or Revision applications, if applicable, 1 page for Specific Aims and 12 pages for the Research Strategy portion. For cores, the page limit is 6 pages.  The component projects should include:

  1. Introduction

For Resubmission or Revision Application only

  1. Specific Aims

State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. Specific aims should be built around serving the goal of this FOA to develop novel technologies and methodologies underpinning high-throughput structural biology.

  1. Research Strategy

a)     Significance

Describe how the project will address the goals of this FOA; to develop novel technologies and methodologies underpinning high-throughput structural biology. If the aims of the project are achieved, how will high-throughput structural biology be improved? Applicants are expected to elaborate on the importance of the problem to be addressed by the proposed project.  A compelling reason for conducting the proposed research should be the focus of this section.

b)    Innovation

Describe the innovative nature of the proposed research. Describe the proposed novel methodologies or technologies to be developed and any advantage over existing methodologies.

c)     Approach

Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Applicants should also discuss the rationale for assembling the research team, including qualifications and selection criteria for the participating investigators and collaborators. Applicants should discuss plans for participation in the PSI:Biology network and plans to deposit their coordinates and other structure data (structure factors or NMR restraints) in the PDB within four weeks of completion and to provide information on structure targets and structure solution to the PS:Knowledgebase TargetDB and PepcDB databases.

If appropriate, provide:

Preliminary Studies for New Applications

The purpose of this FOA is to promote development of novel methods for high-throughput structural biology.  It is anticipated that applicants may not have extensive preliminary data.  New ideas relevant to this FOA may not have been fully tested.  Therefore, applicants should put more emphasis on elaborating the rationale, which may be based on published data from other laboratories, for the proposed studies.  Preliminary data are not required, should be kept to a minimum and will not be a major criterion for review. 

Progress Reports for Renewal/Revision Applications

For renewal/revision applications, provide a Progress Report as part of the Approach section. Provide the beginning and ending dates for the period covered since the last competitive review. Summarize the specific aims of the previous project period and the importance of the findings, and emphasize the progress made toward their achievement. Explain any significant changes to the specific aims and any new directions including changes resulting from significant budget reductions.

Shared Resource Cores

Applicants may propose one or more (as needed) appropriate shared resources, or cores. Administrative cores, except in special, well-justified circumstances, will not be allowed. These cores must not duplicate analogous resources already established in the applicant institutions (although supplemental funding to such existing resources may be requested).  Do not repeat budget pages and biographical sketches. For cores, the page limit is 6 pages using the format of the component projects.  Each shared resource core must have a single designated Core Director. 

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

Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs)  must carry out the following steps:

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

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

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

This policy applies to all new, renewal, revision, or resubmission applications. See NOT-OD-02-004, October 16, 2001.

Appendix Materials

All paper PHS 398 applications submitted 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: Investigators seeking $500,000 or more in direct costs in any year 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/.

Software Sharing Plan       

A software dissemination plan, with appropriate timelines, must be included in the application only if software development is a part of the application.  There is no prescribed single license for software produced through grants responding to this announcement.  However, NIH does have goals for software dissemination, and reviewers will be instructed to evaluate the dissemination plan relative to these goals:

1.  The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. 

2. The terms of software availability should permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.

3. To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

4.  The terms of software availability should include the ability of researchers to modify the source code and to share modifications with other colleagues.  An applicant should take responsibility for creating the original and subsequent “official” versions of a piece of software.

5.  To further enhance the potential impact of their software, applicants must propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others.  This proposal may include a plan to incorporate the enhancements into the “official” core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.

The plan for software sharing will be evaluated during peer review, and the final version of any accepted software sharing plans will become a condition of the award of the grant. The software sharing plan should be included in the Resource Sharing Plan.

The adequacy of the software sharing plans will be considered by program staff when making recommendations about funding applications. In making such considerations, prior to funding, program staff may negotiate modifications of software sharing plans with the Principal Investigator(s) before recommending funding of an application. Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plan.

The final version of any accepted software sharing plans will be referenced as a condition of the award of the grant. The effectiveness of software sharing may be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590).  See Section VI.3., “Reporting.”

Intellectual Property 

An institution's stance must be consistent with the goals of advancing and not hindering future research. Refer to the NIH Intellectual Property Policy for more details. The application should include a written statement from the officials of the institution(s) responsible for intellectual property issues, to the effect that the institution supports and agrees to abide by the NIH Intellectual Property Policy.

Recruitment and Retention Plan

Include this plan under Item 11, “Other Attachments” under Section 4.4 “Other Project Information Component” of the application

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

Applications that are complete will be evaluated for scientific and technical merit by  appropriate peer review groups convened by CSR 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. 

Review Criteria for the Overall Program as a Whole

The overall application will be evaluated as an integrated research effort focused on a central theme.  Individual research projects, supporting cores (if proposed), and program as an integrated effort are collectively considered.   The relationship and contributions of each research project and core to the overall theme of the program project will be discussed and evaluated.  Although projects not recommended for inclusion in the program are not considered in scoring the overall program project, such projects may reflect on the leadership capabilities of the PD(s)/PI(s)

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the program as a whole to develop new methodologies or technologies for high-throughput structural biology. Separate criterion scores for the overall program will not be assigned.

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.

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.

Software Sharing Plan   If software development is proposed, the initial review group will comment on the appropriateness of the proposed software sharing according to the guidelines in Section IV.6.

Review Criteria for Individual Research Projects

Overall Impact. Reviewers will provide an overall impact/priority score for each individual research project 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 core 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 separate criterion scores for each individual project.  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   change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, 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?  If there is an investigator on the research team from a discipline such as mathematics, physics, computer science, statistics or other quantitative discipline and who is new to protein structure modeling, is that investigator contributing in a significant way to the studies proposed?

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 application develop new methodologies or technologies for high-throughput structural biology?

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? Will the plan for collaboration with other members of the PSI:Biology network further the pSI:Biology research goals as described in the Research Objectives section of this FOA?  

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? 

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.

Criteria for Shared Resource Core(s)

Reviewers will assess the technical merit of the proposed core(s) and recommend their inclusion or deletion from the program project. Separate impact/priority scores and criterion scores will not be assigned for core(s).

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:

Section VI. Award Administration Information


1. Award Notices

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

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

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

A formal notification in the form of a Notice of Award (NOA) will be provided to the applicant organization. The NOA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

For commitment to diversity, the final version of any accepted recruitment and retention plan will be referenced as a condition of award.

The final version of any accepted software sharing plan will be referenced as a condition of award.

An agreement to deposit coordinates for homology models in the PSI:Biology Knowledgebase consistent with the requirements in the Research Objectives section of this FOA 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 NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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.

The effectiveness of the interactions with PSI:Biology including deposition of coordinates and structure factors or NMR constraint information in the PDB and participation in the TargetDB and PepcDB project may be evaluated as a part of the administrative review of each progress report.

For software development, the final version of any accepted software sharing plan will be referenced as a condition of award.

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:

Peter C. Preusch, Ph.D.
Acting 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
FAX:  301-480-2004

Email: preuschp@nigms.nih.gov

2. Peer Review Contacts:

Donald Schneider, Ph.D.
Division of Basic and Integrative Biological Science
Center for Scientific Review, Room 5160
6701 Rockledge Dr.
Bethesda, MD 20892
Telephone: (301) 435-1727
Email: schneido@csr.nih.gov

3. Financial or Grants Management Contacts:

Earl C. Melvin
Division of Extramural Activities
National Institute of General Medical Sciences
45 Center Drive, Room 2An.32E, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3912
FAX: (301) 480-2554
Email: melvine@nigms.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

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/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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