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:
High-Accuracy Protein Structure Modeling (R01)

Announcement Type
This is a reissue of RFA-GM-05-008 which was previously released July 8, 2004.

Request For Applications (RFA) Number:
RFA-GM-07-003

Catalog of Federal Domestic Assistance Number(s)
93.859

Key Dates
Release Date: May 1, 2006
Letters of Intent Receipt Date: September 25, 2006
Application Receipt Date(s): October 23, 2006
Peer Review Date(s): March 2007
Council Review Date(s): May 17-18, 2007
Earliest Anticipated Start Date(s): July 1, 2007
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: October 24, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
       1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

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

Background

The NIGMS launched its structural genomics program, the Protein Structure Initiative (PSI), in 2000.  The long-range goal of the PSI is to make three-dimensional (3D) atomic level structures of most proteins easily obtainable from knowledge of their corresponding DNA sequences.  The PSI plans to accomplish this goal by the creation and distribution of a large collection of protein structures.  High-throughput structure determination by X-ray crystallography and NMR will achieve a systematic sampling of major protein sequence families.  These experimentally determined structures will be used as templates for computational modeling of homologous proteins to produce structural coverage of a majority of sequenced genes. 

The PSI research centers are making rapid progress on the experimental front.  During the initial five-year pilot phase, efficient large-scale structure determination pipelines were successfully developed at several PSI centers.  More than a thousand structures of carefully selected proteins were determined.  The majority of these PSI structures are novel structures that have 30% or lower sequence identity to previous PDB depositions, and therefore, are highly valued in covering sequence space.  Following thorough evaluation and discussion among Institute staff and at NIGMS Council meetings, a five-year production phase (PSI-2) was launched in July 2005 (http://www.nigms.nih.gov/psi).  The newly awarded production centers are continually ramping up their structure output capacity.  It is anticipated that the production of non-redundant structures produced by the structural genomics centers will be close to one thousand per year in the coming years.  These structures will rapidly expand structural coverage of sequenced genes and enable high-resolution modeling of several hundred thousand proteins.  The value of these structural models in biological research depends critically on their quality.  Development of high-accuracy computational methods that reliably generate near-experimental quality structural models will be essential for capitalizing on the PSI investment, and thus will benefit all biomedical researchers relying on structural information of proteins for their functional investigations. 

Unlike the rapid advances made in experimental structure determination, progress in computational structure prediction has been incremental as illustrated at the recent CASP (Critical Assessment of Techniques for Protein Structure Prediction, http://predictioncenter.org) competitions.  Predictions that rely on closely related template proteins with known structures in general have much higher quality than ab initio methods.  Reliability of these “homology modeling” or “comparative modeling” methods depends critically on the level of sequence identity between the modeling target and the template.  When sequence identity is 30% or higher, backbone atoms are usually correctly modeled.  The majority of the errors come from side-chain and loop placement during refinement with roughly 3-4 angstrom root mean square deviation (RMSD) compared to high-resolution X-ray crystal structures.  When the sequence identity drops below 30%, misalignment occurs frequently and model quality suffers dramatically.  To increase the utilization and value of the computational models in biomedical research, and to reduce the need for still costly experimental structure determination, significant improvement in the reliability and accuracy of modeling techniques is acutely needed.

Recognizing the need for much improved protein structure modeling technology, the NIGMS organized a High-Accuracy Comparative Modeling Workshop soliciting community input in October, 2003.  The workshop participants identified some specific areas as bottlenecks for further development of protein structural modeling.  A workshop summary is published on the NIGMS website (http://www.nigms.nih.gov/News/Meetings/NIGMSWorkshopOnHighAccuracyComparativeModeling.htm). 

Following the Workshop, a RFA that established the Protein Homology Modeling program was published in the NIH Guide on July 8, 2004 (http://grants.nih.gov/grants/guide/rfa-files/RFA-GM-05-008.html).  The current announcement is a reissue of RFA-GM-05-008 with the same objective but a change in mechanism from the P20 Exploratory Center to the R01 Research Grant.  The goal of this program is to foster scientific progress in computational protein structure prediction that will reliably produce models with accuracy close to experimentally determined X-ray crystal structures.  In order to achieve this goal, novel concepts and strategies are needed to significantly improve current comparative modeling methods.  Close collaborations among creative researchers with various training backgrounds and expertise are expected to provide cross fertilization for the development of new approaches.  Although the hurdles are still high, the potential payoff and impact will be dramatic.  The ultimate goal is a paradigm shift in structural biology, so that experimental structure determination for soluble single proteins will become unnecessary, and more resources and effort can be put into characterizations of complexes and more difficult targets.  Eventually, accurate structural information will be available for all gene products.

Objectives

Applicants of this RFA should be focusing on one or both of the following two main goals (also see Award Criteria):

1) Near-Crystal Structure Quality for Close Homologs of Known Structures

The first scientific goal of this RFA is to approach the standard of high-resolution X-ray crystal structure quality for comparative models that are based on known structures with 30% or higher sequence identity to the modeling targets.  This is predominantly a high-accuracy refinement problem, although substantial improvement of alignment methods is also required.  The aim is to acquire the ability to reliably produce computational models with highly accurate placement of both backbone and side chain atoms, and to significantly reduce the need for experimental structure determinations for close homologs of known structures.

2) High-Accuracy Models for Remote Homologs of Known Structures

The second scientific goal is to expand the modeling coverage to more distantly related proteins that exhibit as low as 10% identity to any known structures.  The quality of these models should be close to X-ray structures or high-resolution NMR structures with less than 2 angstrom RMSD for backbone and side-chain atoms.  This is both an alignment problem and a refinement problem.  Significant improvement of modeling methods is needed to push the modeling coverage to remote homologs of existing structures without much compromise on quality.

Through this RFA, the NIGMS is committed to achieving both of these two goals (see Award Criteria).  Applicants must identify which of the modeling goals (or both) the proposal addresses.  Applicants may propose intermediate goals and deliverable milestones within the funding period.  Although not the main goal, some practical applications of structure modeling can be incorporated as components of the research.  These may include: establishing benchmarks and standards for model quality assessment and uncertainty estimation; developing methods that will accurately predict structural changes caused by small mutations; combining computational approaches and high-throughput experimental approaches to develop novel hybrid methods; improving ab initio methods for loop modeling; improving server and meta-server methods; collaborating with other scientists to promote utilization of models in functional studies.  Applicants may also propose other research, but all activities must be in support of targeting the main goals above.

The NIGMS strongly encourages potential applicants to discuss their ideas with Institute program staff prior to submission to ensure that the application will be responsive to the mission and intent of this RFA.

Special Requirements

This RFA aims to promote collaborative research and exploratory approaches in developing novel comparative modeling technology.  It is expected that a cohesive group of two to three investigators should form the body of the research team.  The level of originality in research design and the degree of complementarity of collaborating investigators will be important review considerations.  Plans should be presented in the application to integrate efforts from individual investigators.  Applications from new investigators and established investigators in mathematics, physics, computer science, statistics, or other quantitative disciplines who are new to protein structure modeling are strongly encouraged.  Investigators currently supported to work on protein homology modeling are eligible to apply.  However, their contributions to this program must not overlap with or be simple extensions of their supported studies.

The technologies developed under this program should be generalizable and scalable for applications to a broad range of proteins, rather than to a limited number of special groups of proteins. 

This program is a component of the PSI.  Collaboration with the PSI research centers (http://www.nigms.nih.gov/Initiatives/PSI/Centers/) is encouraged.   Examples of collaboration may include modeling proteins that are homologs of the structures determined by the PSI centers, modeling structural genomics targets prior to release of their experimental structures by the PSI centers for quality assessment of the modeling algorithms, providing feedback to PSI centers for refinement of target selection strategies, or development of hybrid approaches by combining computational methods with high-throughput experimental data to increase model quality.  Other forms of collaboration with the PSI centers or other large-scale experimental structure determination projects are also encouraged.  Additional plans to engage the user community and to solicit feedback to improve quality and utilization of models should also be included.

Software 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 applicant 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 proposal.  The plans for data and software sharing will be evaluated during peer review and must be approved by NIGMS staff prior to award.

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the R01 award mechanism.

As an applicant, you will have primary responsibility for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/modular/modular.htm).

2. Funds Available

The NIGMS intends to commit approximately $1.6 million dollars in total cost in FY 2007 to fund up to five new grants in response to this RFA. An applicant may request a project period of up to three years and a budget for direct costs up to $225,000 per year.

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 may also vary. Although the financial plans of the IC provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

1.B. Eligible Individuals

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

2. Cost Sharing or Matching

Cost sharing or matching is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

None

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 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 most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

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

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: September 25, 2006
Application Receipt Date(s): October 23, 2006
Peer Review Date(s): March 2007
Council Review Date(s): May 17-18, 2007
Earliest Anticipated Start Date(s): July 1, 2007

3.A.1. Letter of Intent

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Jiayin (Jerry) Li, M.D., Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences, NIH
45 Center Drive, Room 2As.19F, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0828
FAX: (301) 480-2004
Email: lij@nigms.nih.gov


3.B. Sending an Application to the NIH

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

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


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

At the time of submission, two additional copies of the application and all copies (5) of the appendix material must be sent to:

Helen R. Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences, NIH
45 Center Drive, Room 3An.12F, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
FAX: (301) 480-8506
Email: sunshinh@nigms.nih.gov


Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIGMS. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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


6. Other Submission Requirements

Application Instructions

Applicants should follow the general instructions for PHS 398 application form with the exception of specific instructions relevant to this RFA given below.

1. Description (Page 2) 

In the Description, applicants should describe concisely the goal(s) of the research, the innovative nature of the strategy, tasks to be carried out by each investigator, and the specific target to be reached at the end of the project period. 

2. Research Plan 

The total page limit for items a-d of this section is 20 pages.

Item a: Specific Aims
The two main goals of this RFA are to increase model quality to a level comparable to high-resolution X-ray crystal structures when known structures are available with 30% sequence identity to the modeling targets, and to increase model quality to 2 angstrom RMSD or better when known structures are available with as low as 10% identity to the targets.  Specific aims should be built around serving one or both of these two main goals.  Applicants may want to propose intermediate steps to a longer-term goal that are well defined and achievable in the project period. 

Item b: Background and Significance 
Applicants are expected to elaborate on the current state of the art, technical bottlenecks, innovative nature of the proposed research, and its capabilities and potential impact on biomedical research.  A compelling reason for conducting the proposed research should be the focus of this section.

Item c: Preliminary Studies/Progress Report 
The purpose of this RFA is to promote development of novel ideas and approaches through close collaboration among researchers with different research backgrounds.  It is anticipated that applicants may not have extensive preliminary data.  New ideas relevant to this RFA 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 (within two pages), and will not be a major criterion for review.  Applicants should also discuss the rationale for assembling the research team, including qualifications of the members. 

Item d: Research Design and Methods 
This section should carefully explain how the specific aims will be accomplished.  In addition, what is the unique contribution of each investigator?  How will the interdependent collaboration be effective in carrying out the research?  If there are doubts about the outcomes for early stages of the work, what are the contingency plans?  What are the milestones and clear deliverables in this grant period?  What is the long-term goal and plan for this work?  What are the plans for dissemination of results and software developed to the research and user communities?   

Specific Instructions for Modular Grant applications

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Plan for Sharing Research Data

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared.

The reasonableness of the data sharing plan will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.


Section V. Application Review Information


1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

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

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

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score.

Significance: Does this study address the main goals of this RFA as specified in the Objectives section? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? If the study is successful, would it lead to a substantial advance in protein structure modeling?  Rather than focusing on a special kind of protein, how successful will the method be adopted to model a broad range of protein families? What will be the benefit to the research community if the proposed studies are supported?

Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?  How likely is it that the project will achieve its goals in a timely fashion as outlined in the application?  Is the proposed study substantially different from the participating investigators’ on-going funded research?  (Preliminary data is not required and therefore is not a major review criterion.) 

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?    

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project? Are the participating investigators new investigator(s), established investigator(s) in other fields, or established investigator(s) in protein structure modeling?  What are the track records of the investigators in their respective fields?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

Not applicable.

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The NIGMS will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy expects that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

The earliest anticipated award date will be in March 2007.

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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

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

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.


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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

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:

Jiayin (Jerry) Li, M.D., Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
45 Center Drive, Room 2As.19F, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0828
FAX: (301) 480-2004
Email: lij@nigms.nih.gov


2. Peer Review Contacts:

Helen R. Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, Room 3An.12F, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
FAX: (301) 480-8506
Email: sunshinh@nigms.nih.gov


3. Financial or Grants Management Contacts:

Grace Olascoaga
Division of Extramural Activities
National Institute of General Medical Sciences
45 Center Drive, Room 2An.32E, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-5520
FAX: (301) 480-2554
Email: olascoag@nigms.nih.gov


Section VIII. Other Information


Required Federal Citations

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

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


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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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

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


URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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


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NIH Funding Opportunities and Notices


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