RFA-GM-09-009: NIGMS National Centers for Systems Biology (P50)

Department of Health
and Human Services (HHS)

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Part I Overview Information

Department of Health and Human Services

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

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

Title: NIGMS National Centers for Systems Biology (P50)

Announcement Type
This is a modification of RFA-GM-08-004.

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

August 20, 2009 - This RFA has been reissued as (PAR-09-258).
August 22, 2008 - See Notice (NOT-GM-08-133) Change in Contact Information.

Request For Applications (RFA) Number: RFA-GM-09-009

Catalog of Federal Domestic Assistance Number(s)
93.859

Key Dates
Release Date: June 16, 2008
Letters of Intent Receipt Date: September 24, 2008
Application Receipt Date: October 24, 2008
Peer Review Date(s): March-April 2009
Council Review Date: May 2009
Earliest Anticipated Start Date: July 1, 2009
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: October 25, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose. The National Institute of General Medical Sciences (NIGMS) invites applications for National Centers for Systems Biology. The goal of the program is to promote institutional development of pioneering research, research training, and outreach programs focused on systems-level inquiries of biomedical questions within the NIGMS mission. The NIGMS supports fundamental inquiries focused on bioinformatics and computational biology, molecular and cell biology, biophysics, genetics and developmental biology, biochemistry, pharmacology, anesthesiology, and human physiology in the areas of trauma, burn, inflammation, and multi-organ failure. The NIGMS does not support research focused on diseases or organ systems that are the domain of other Institutes and Centers within the NIH (http://www.nih.gov/icd/).
Mechanism of Support. This FOA will utilize the P50 Specialized Center grant mechanism.
Funds Available and Anticipated Number of Awards. The total amount of set-aside that the NIGMS expects to award through this announcement is up to $7 million per year. The anticipated number of awards is up to two.
Budget and Project Period. An applicant may request a project period of up to five years and a budget in direct costs up to $2 million per year.
Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization 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.
Number of PDs/PIs. Only one PD/PI will be allowed to be designated on the application.
Number of Applications. An institution may submit more than one application in response to this FOA, provided they are scientifically distinct. More than one award may be made to a single institution but only in the case where these awards have no scientific overlap and serve different communities. In addition, training efforts of funded Centers within the same institution must be highly integrated.
Resubmissions. Resubmission applications from previous releases of this FOA (see section III.3) will be accepted; however, such applications must include an Introduction addressing the previous peer review critiques (Summary Statement).
Renewals. Renewal applications are permitted in response to this FOA. However, only one successful renewal will be allowed, making the total length of support under this program to be limited to a maximum of ten years.
Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates.
Application Materials. See Section IV.1 for application materials.
Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY 301-451-5936.

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, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Background

Medical, biotechnological, and other applications of biological knowledge increasingly depend on our ability to understand the principles that explain the behavior of the system as a whole. Whether the goal is to comprehend basic physiology and disease processes, to identify specific targets for drug intervention, or to prevent the spread of emerging infectious diseases, the challenge is to achieve a level of understanding that enables prediction. Predicting quantitatively how a complex system will behave under defined conditions is a challenge in its own right. For biological systems, this problem is daunting.

Systems Biology is developing as an integrated experimental, informational, and computational science. It has benefited from advances in genomics, proteomics, metabolomics, and other high-throughput technologies and is driven by innovations in computational analysis and simulation. Now biologists pay more attention to understanding how biological components work together to produce system behaviors instead of focusing exclusively on individual molecules and pathways. The adoption of a systems approach is providing new knowledge in many areas of biomedical research from cell dynamics and signaling networks to global metabolism and drug development. It is expected that new, fundamental rules governing systems behavior at various organizational levels will emerge from these studies. However, there are significant conceptual, technological, and cultural challenges to the realization of the systems biology goals. It is the purpose of this initiative to promote innovative responses to these challenges.

Conceptual Challenges. Systems biology is an interdisciplinary science that derives from biology, mathematics, computer science, physics, engineering, and other disciplines. The infusion of theories and techniques from other fields and their integration to establish unique methodologies in problem definition, hypothesis generation, and project execution is a major challenge. Most biological systems are too complex for even the most powerful computational models to capture all the system properties. A useful model, however, should conceptualize the system under study and provide reliable predictive values. To accomplish this, a certain level of abstraction may be required that focuses on the system properties of interest while neglecting some of the other details. In this regard, there is a need for additional research on such issues as system modulation, parameter setting and optimization, and model scalability, with the goal of learning how models can be usefully employed to understand and predict biological behavior. An attractive way to achieve this goal is to develop collaborations between biologists and experts from other fields. Such interdisciplinary collaborations will likely provide the inspiration for the generation of new conceptual thinking, as well as new systems biologists.

Technological Challenges. Currently, technological deficits exist in both computation and experimentation. These include lack of standards and quality control measures in data collection and software engineering. Vast amounts of data from high-throughput experiments provide unprecedented opportunities for computational biologists. However, a high level of heterogeneity in data quality and experimental conditions hampers data comparison, integration, and application in computational modeling. Similar issues exist in software development. The lack of software engineering standards and sufficient documentation has limited software usability and resulted in unnecessary duplication of efforts. Experimentally, there is a demand for the development of novel (and low-cost) methodologies to miniaturize, standardize, and automate high-throughput data collection. Dynamic measurement of living systems at multiple scales that allows digitalization and integration into realistic modeling processes is another substantial challenge. The Systems Biology Centers are encouraged to develop innovative approaches to address these challenges.

Cultural and Educational Challenges. Building cohesive multi-disciplinary research teams by integrating expertise across traditional disciplinary boundaries at the institutional level is not a simple undertaking. A goal of this initiative is to encourage leadership in creating such teams. In the larger research community, there is a need for leadership to disseminate new knowledge and to reduce excessive overlap and redundancy in project selection and tool development. Centers are expected to promote communication, collaboration, and technology and data sharing. Another aspect to be nurtured is the dialog between theory and experiment. The goal is to develop continuous communication and feedback among experimentalists and theoreticians through the entire life of a project. Transforming data into systems knowledge and principles will require iterative cycles of data collection, model generation, and model validation. Finally, the emergence of a new science demands an adequate, diverse workforce of appropriately trained scientists. The future leaders of systems biology research will be knowledgeable and skilled in both experiment and computation. Innovation in education, therefore, is a significant task of the Systems Biology Centers.

The NIGMS strongly supports the analysis of complex biological systems through investigator-initiated research project grants, using the R01, P01, and other appropriate grant mechanisms. However, the resources needed to conduct the multi-faceted, multi-disciplinary projects may be beyond the scope of the typical R01 or P01 grant. Therefore, this FOA presents an opportunity for applicants to assemble unique teams of researchers from diverse disciplines that may not be possible with other funding mechanisms.

Scope of Research

NIGMS intends to promote development of systems biology and broad applications of systems biology approaches to areas that are central to the Institute’s mission of supporting basic biomedical and behavioral research. Recognizing systems biology as an emerging and evolving field with various definitions, for the purposes of this FOA, NIGMS defines systems biology as a discipline at the intersection of biology, mathematics, engineering, and the physical sciences that integrates experimental and computational approaches to study and understand biological processes in cells, tissues, and organisms. Studies at the systems level are distinguished not only by their quantitative nature in data collection and mathematical modeling, but also by their focus on interactions among individual elements such as genes, proteins, and metabolites. These studies often integrate data from multiple levels of the biological information hierarchy in an environmental and evolutionary context and pay particular attention to dynamic processes that vary in time and space. Successive iterations of experiment and theory development are characteristic of systems biology. When applied to human health, systems biology models are intended to predict physiological behavior in response to natural and artificial perturbations and thereby contribute to the understanding and treatment of human diseases. Research areas that historically have been computationally based (e.g., molecular structure modeling) are excluded as a focus of this Center program. Research projects focusing on specific disease processes other than shock, trauma, and burn as well as research on specific organ systems that are the domain of other NIH Institutes and Centers are not eligible. NIGMS mission areas that are relevant to systems biology include, but are not limited to, studies on:

Development of multi-scale modeling approaches and integration of physiological studies at multiple levels
Predictive pharmacology and toxicology through the application of systems approaches to understand drug pharmacokinetics and pharmacodynamics (including absorption, distribution, metabolism, excretion, and interactions at target sites) from the cellular level to the whole-body level
The organization, interaction, and dynamics of cellular network systems (e.g., signaling networks, genetic networks, metabolic networks, etc.)
Fundamental mechanisms of cellular processes, such as transcriptional and translational regulation, cell cycle control, apoptosis, cell differentiation, cell division, cell migration, intracellular transport, membrane and organelle biogenesis, energy generation and utilization, host-pathogen interactions, intercellular communications, etc.
Genetic variations in relation to complex phenotypes and their evolutionary and environmental context
Pattern formation and other developmental processes in model systems (e.g., Drosophila, C. elegans, stem cells, etc.)
Organ-system networks involved in multi-organ failure in shock, trauma, and burn injury
Behavioral aspects of complex systems, such as neurogenetics of the neural networks that control complex behaviors, behavioral aspects of circadian rhythmicity in non-human model systems, and social behaviors of model systems
Design and construction of synthetic biological systems to better understand the underlying organizational principles and to obtain new features and utilities relevant to biomedicine

Leadership Development

NIGMS National Centers for Systems Biology are expected to provide national leadership in systems biology research, research training, and knowledge dissemination. They will accomplish this goal through the development of truly innovative programs that are expected to establish new research areas and a new research culture, to develop and distribute enabling technologies, and to train a new generation of systems biologists. Centers should design their programs with the goal of serving scientific communities beyond the participating investigators and institutions. This can be achieved through research collaborations, facility support, visiting investigatorships, fellowships, workshops, summer courses, internships, symposia, Center websites, and/or other means. Research training and education should be a significant component of the Centers. To maximize the impact, Centers should conduct research training at multiple levels from undergraduate education to professional career development that are appropriate to their institutions. At the student level, applicants are expected to identify current educational gaps and needs and to propose creative responses. At the professional level, Centers should propose plans to support and nurture junior and new investigators. Incorporation of developmental research projects led by new investigators in the Center research and development plan is strongly encouraged. Outreach to the groups of individuals underrepresented in biomedical research is required (see Special Requirements below). Over a period of time, Centers should evolve into highly integrated research, training, and knowledge-exchange headquarters that will make substantial contributions in the emerging field of systems biology.

Successful Centers should provide their home institutions with the means to implement organizational and professional changes that will make systems biology research an attractive career option for both established and entry-level investigators. A variety of organizational models is possible, and it is not the intent of this announcement to prescribe any particular one.

Special Requirements

Recruitment and Retention Plan to Enhance Diversity
The NIH recognizes a compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their trainee and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/). Nationally, groups found to be underrepresented in biomedical and behavioral research include, but are not limited to, African Americans, Hispanic Americans, Native Americans (including Alaska Natives), and natives of the U.S. Pacific Islands. In addition, it is recognized that underrepresentation 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 encouraged to participate in this program.

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/indix.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program, or they 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 scope and nature of systems biology studies provide an excellent opportunity to enhance diversity of the biomedical research workforce. Whereas recruitment at all career levels is appropriate, applicants are encouraged to establish programs that give priority to the undergraduate through professional career levels. These activities must be integrated in the ongoing research and educational activities of the Center. Applicants must describe their specific plans for and recent experience with the recruitment and selection process. Furthermore, the Center must establish an outreach coordinator position who will be responsible for, among other outreach tasks, leading the recruitment effort, overseeing selection and placement of trainees, assessing academic and research progress of students, etc. Development of partnerships with minority and minority-serving institutions and organizations is also encouraged. Information on relevant minority-serving institutions may be obtained by consultation with staff of the NIGMS Division of Minority Opportunities in Research (http://www.nigms.nih.gov/Minority/). This FOA requires all applicants to submit a recruitment and retention plan to enhance diversity, which will be evaluated by reviewers in the determination of scientific merit and priority score of the application.
Other NIH funding opportunities exist that can be utilized by funded projects to obtain supplemental support to promote diversity in biomedical research. Those are described in a separate announcement (http://grants.nih.gov/grants/guide/pa-files/PA-05-015.html).
Renewal (Competing Continuation) and Administrative Site Visit
Only one renewal will be allowed for each award, making the total length of support for any P50 Center under this program limited to a maximum of ten years. During the third year of the first grant cycle, the Center will receive an administrative site visit to evaluate the Center’s progress on research, education, outreach, and diversity recruitment efforts. The fifth year of funding will depend on the outcome of that administrative review, and the PI will receive advice about NIGMS interest in accepting a renewal application to extend the initial award.
Project Director/Principal Investigator Effort
The Project Director/Principal Investigator of a Center grant must commit a minimum effort of 30% or 3.6 months per year to the project.
Scientific Advisory Board
The Center will be expected to have a Scientific Advisory Board, drawn from experts outside the project. These advisors will meet annually to review and provide guidance on Center activities. While a description of the Board's activities should be included in the application, potential members of the Board should not be contacted, named, or selected until an award has been made. This stipulation will allow a wider pool of potential reviewers of the application. Costs and justifications for activities of the Board should be included in the application. Renewal applications should list individuals who have served or currently serve in this capacity.
Program Annual Meeting
Funded Centers are required to attend annual meetings of the NIGMS National Centers for Systems Biology Program, in order to present results and to communicate with other Centers. For the purpose of preparing an appropriate budget, it should be presumed that at least two representatives of each Center (including the PI) will attend this annual meeting. Participating faculty, graduate students, postdoctoral associates, Center staff, and scientific advisory board members all are encouraged to attend the scientific sessions of the annual meeting.

Each meeting will be hosted by one of the Centers, in turn, and it will be the responsibility of the hosting Center to plan the program (with approval from NIH staff) and to advise attendees regarding local arrangements. At its discretion, NIGMS may consider the award of supplemental funds to defray the allowable costs incurred in hosting the meeting; however, all requests for supplemental funds must include verification that funds are not otherwise available to cover these costs and could not be made available by rebudgeting from other cost categories.

Center Website
Applicants should have a plan to construct a Center website for the dissemination of research data, software, and other resources of the project. To the extent that established public databases have the capability for collecting and disseminating the data that would be collected under the grant, it is NIGMS' strong preference that a plan for the rapid deposition of data into such public databases also be described in the application.
Plan for Software Sharing
A software dissemination plan, with appropriate timelines, must be included in 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 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, and should provide a plan to manage the dissemination or adoption of improvements or customizations of that software by others. This plan should include a method to distribute other user's contributions such as extensions, compatible modules, or plug-ins.

Since the inception of the National Centers for Systems Biology Program in 2001, the NIGMS has established ten P50 Centers (http://www.nigms.nih.gov/Initiatives/SysBio/). Potential applicants are encouraged to view the websites of funded Centers, to discuss their ideas with NIGMS program staff, and to send a letter of intent prior to submission to ensure that the application will be responsive to the mission of NIGMS and the intent of this FOA. Research conducted by future new Centers should complement the projects already funded. New Center applications that will make unique contributions to the program and expand the areas of research of existing Centers will be given higher priorities in funding considerations.

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 will use the P50 Specialized Center award mechanism(s).
The Project Director/Principal Investigator (PD/PI) 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 NIGMS intends to commit up to $7 million in total cost in FY 2009 to fund up to two new and/or renewal applications in response to this FOA. Future year amounts will depend on annual appropriations. An applicant may request a project period of up to five years and a budget in direct costs up to $2 million per year. Funds for initial large equipment may be requested in excess of the $2 million limit if prior approval is obtained from staff responsible for Scientific/Research issues, listed in Section VII.1. The fifth year support of new awardees is conditional on a successful administrative site visit in the third year. The earliest anticipated start date is July 1, 2009.

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 NIGMS 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.

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:

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Eligible Agencies of the Federal Government

Foreign Institutions are not eligible to apply.

1.B. Eligible Individuals

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

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

An unfunded application submitted in response to the previous releases of this FOA (RFA-GM-08-004, RFA-GM-07-004, RFA-GM-05-010, RFA-GM-03-009, RFA-GM-03-002, and RFA-GM-01-001) may be submitted as a resubmission application. A resubmission application must include an Introduction addressing issues raised in the previous critiques (Summary Statement). The page limit for the Introduction is five pages.

Renewal applications will be permitted for this FOA. However, only one successful renewal will be allowed, making the total length of support to be limited to a maximum of ten years.

Applicant institutions may submit more than one application, provided each application is scientifically distinct.

Only one PD/PI will be allowed to be designated on the application.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: 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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

Budget:
Budgets for each component of the Center application and a composite overall budget should be included in the application.

Research Plan:
Research, education, and outreach are the three main components of a Center project. It is up to the applicants to decide how to best organize their Center program to achieve its missions. Commonly, a Center project includes synergistic research and technology development projects, core facilities for research support, training programs, and outreach programs. Training and outreach initiatives can be organized as integral components of all projects and cores or alternatively as standalone projects or cores. Because of the complexity of a Center program, the importance of a clear and efficient management plan can not be overstated. This critical function can be performed by an administrative core or other similar structures.

Rather than divided into several sections where each describing an autonomous subproject, the Center proposal should be presented as a whole and include the following components in this order:

Introduction (for resubmission applications)
Program Summary (include mission, specific aims, and milestones of the Center)
Organizational Structure and Management Plan
Progress Report (for renewal applications)
Research Projects and Preliminary Studies
Core Facilities
Research training and Education
Outreach and Dissemination
Recruitment and Retention Plan to Enhance Diversity
Plans for Intellectual Property Handling and Data/Resource/Software Sharing

A timeline for the project should be presented. This timeline should outline how the project's goals can be met within the time frame of the grant. The timeline also will assist the investigators and the NIGMS and its advisors in evaluating progress toward the project's goals.

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

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 24, 2008
Application Receipt Date: October 24, 2008
Peer Review Date(s): March-April 2009
Council Review Date: May 2009
Earliest Anticipated Start Date: July 1, 2009

3.A.1. Letter of Intent

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

Descriptive title of proposed research
Name, address, and telephone number of the Principal Investigator
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

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

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Jiayin (Jerry) Li, M.D., Ph.D.
Center for Bioinformatics and Computational Biology
National Institute of General Medical Sciences, NIH
45 Center Drive, Room 2As.55C, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 451-6446
FAX: (301) 480-2802
Email: lij@nigms.nih.gov

3.B. Sending an Application to the NIH

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

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

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

At the time of submission, two additional copies of the application and all copies of the appendix 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

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, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the NIGMS. Incomplete and/or 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.

Resubmission applications from previous releases of this FOA (see section III.3) will be accepted; however, such applications must include an Introduction addressing the previous peer review critiques (Summary Statement)

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 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 and Information

Research Plan Page Limitations

The page limit for the Research Plan section of the application is 80 pages. Please note that there is no requirement to submit the maximum number of pages; instead, concise, articulate applications are desired. The page limit for the Introduction of resubmission applications is five pages.

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

Resource Sharing Plan(s)

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

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

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

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

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

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

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

Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned a priority score.
Receive a written critique.
Receive a second level of review by the National Advisory General Medical Sciences Council.

The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as determined by peer review
Availability of funds
Relevance of the proposed project to program priorities and balances (e.g., Will the proposed Center make unique contributions and expand the areas of research funded in the existing Centers?)
Adequacy of plans for research data, research resources, and software sharing

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 meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

The following general (NIH-wide) criteria will be used in evaluating applications:

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

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 (if applicable)?

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?

Criteria Specific to this FOA

In addition to the standard NIH-wide criteria, the following FOA-specific criteria will be used to evaluate specific aspects/components of the P50 applications.

Significance: How big an impact will the proposed Center have on serving the needs of the biomedical research community? Does the application provide convincing evidence that the Center, if funded, will become a leader in research, technology development, research training, knowledge exchange, and community development? For renewal applications, has the Center demonstrated success in achieving this goal?

Approach: Is the management plan adequate and sufficiently flexible to allow addition of new projects and termination of projects that have successfully acquired other sources of support or have underperformed? What is the plan to foster development of new investigators? Are the Center s plans for research training, outreach, and recruitment and retention to enhance diversity adequately described? Is the plan for an Advisory Board to provide scientific and managerial oversight appropriate? Will the research resources, including software and data generated by the project, be shared with the larger community and be easily accessible? For renewal applications, how effective was the Center’s diversity recruitment and retention effort?

Innovation: Are there innovative features in the organizational design, decision making, training, and outreach plans?

Investigators: Is the level of effort proposed for the PI and other Key Personnel adequate? Are the participating investigators well chosen for their roles in the collaborative project? For renewal applications, has the PI demonstrated effective leadership role in the previous funding period?

Environment: What impact will the funded Center have on its participating institutions? For renewal applications, has the Center demonstrated success in promoting the development of interdisciplinary research and education culture in its home institution(s)? Are the relationships between the proposed Center and other related programs within the institution clearly laid out? Do they complement each other?

NIH considers the following in evaluating Center grant applications:

The scientific and technical merit of the proposed program;
The qualifications and experience of the center director and other key personnel;
The statutory and program purposes to be accomplished;
The extent to which the various components of the proposed program would be coordinated into one multi-disciplinary effort within the center;
The extent to which the center's activities would be coordinated with similar efforts by other organizations;
The administrative and managerial capability of the applicant; and
Other factors which the awarding IC considers appropriate in light of its particular statutory mission.

2.A. Additional Review Criteria:

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

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

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

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).

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

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

2.B. Additional Review Considerations

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

2.C. Resource Sharing Plan(s)

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

Data Sharing Plan. [http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm]
Sharing Model Organisms. [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html]
Genome Wide Association Studies (GWAS). [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html]

3. Anticipated Announcement and Award Dates

The earliest anticipated award date will be in July 2009.

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.

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 NoAd 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/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

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 Annual Progress Report is due two months prior to the grant anniversary date. It should be sent to:

Division of Extramural Activities Support, OER
National Institutes of Health
6705 Rockledge Drive, Room 2207, MSC 7987
Bethesda, MD 20892-7987 (for regular or US Postal Service Express mail)
Bethesda, MD 20817 (for other courier/express mail delivery only)
Phone Number: (301) 594-6584

There is no specific page limit on the progress report. It should include the following information: an overview of the major achievements made in the previous year including status on meeting the milestones, organizational and personnel changes, research progress, education and training activities, outreach activities, data and resource sharing, and intellectual property issues.

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:

Jiayin (Jerry) Li, M.D., Ph.D.
Center for Bioinformatics and Computational Biology
National Institute of General Medical Sciences
45 Center Drive, Room 2As.55C, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 451-6446
FAX: (301) 480-2802
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.32C, 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

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

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

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

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

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

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

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.

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.

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

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

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

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

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

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

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

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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